PlainRecalls
FDA Devices Verify with FDA Devices → Moderate Class II Terminated

1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2.0 X 16 CORT SCREW HEX/S 2.0 X 16 CORT SCREW CRUCI 2.0 X 18 CORT SCREW CRUCI 2.0 X 20 CORT SCREW CRUCI 2.0 X 26 CORT SCREW CRUCI 2.0 X 28 CORT SCREW CRUCI 2.0 X 30 CORT SCREW CRUCI 2.0 X 32 CORT SCREW CRUCI 2.0 X 34 CORT SCREW CRUCI 2.0 X 36 CORT SCREW CRUCI 2.0 X 38 CORT SCREW CRUCI 2.0 X 40 CORT SCREW CRUCI 2.0 X 42 CORT SCREW CRUCI 2.0 X 44 CORT

Reported: February 26, 2014 Initiated: October 11, 2013 #Z-1042-2014 7,044,680 total units

Zimmer, Inc. issued this FDA Devices recall on February 26, 2014. Classified as Moderate severity (Class II). Approximately 7,044,680 total units are affected. The recall was issued because: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facili…. This recall notice is sourced from official FDA Devices enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

Recall Insight

This FDA Devices action (record #Z-1042-2014) was formally reported on February 26, 2014, with the manufacturer initiating the action on October 11, 2013. It is classified under Moderate severity (Class II), with a current status of Terminated. Zimmer, Inc. is listed as the recalling firm, operating out of Warsaw, IN. Federal records indicate 7,044,680 total units are affected, placing this recall in the million-unit bracket that typically triggers nationwide consumer alerts and retailer sweeps.

The documented reason for this recall is: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations cond… Distribution data in the federal record shows the product reached: Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Ze…. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 12 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

7,044,680 total

Related Recalls

6

6 from same agency

Product Description

1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2.0 X 16 CORT SCREW HEX/S 2.0 X 16 CORT SCREW CRUCI 2.0 X 18 CORT SCREW CRUCI 2.0 X 20 CORT SCREW CRUCI 2.0 X 26 CORT SCREW CRUCI 2.0 X 28 CORT SCREW CRUCI 2.0 X 30 CORT SCREW CRUCI 2.0 X 32 CORT SCREW CRUCI 2.0 X 34 CORT SCREW CRUCI 2.0 X 36 CORT SCREW CRUCI 2.0 X 38 CORT SCREW CRUCI 2.0 X 40 CORT SCREW CRUCI 2.0 X 42 CORT SCREW CRUCI 2.0 X 44 CORT SCREW CRUCI 2.0 X 46 CORT SCREW CRUCI 2.0 X 48 CORT SCREW CRUCI 2.0 X 50 CORT SCREW CRUCI 2.7MM CORT. SCREW 6MM, ST 2.7MM CORT. SCREW 7MM, ST 2.7MM CORT. SCREW 8MM, ST 2.7MM CORT. SCREW 9MM, ST 2.7MM CORT. SCREW 10MM, S 2.7MM CORT. SCREW 12MM, S 2.7MM CORT. SCREW 14MM, S 2.7MM CORT. SCREW 16MM, S 2.7MM CORT. SCREW 18MM, S 2.7MM CORT. SCREW 20MM, S 2.7MM CORT. SCREW 22MM, S 2.7MM CORT. SCREW 24MM, S 2.7MM CORT. SCREW 26MM, S 2.7MM CORT. SCREW 28MM, S 2.7MM CORT. SCREW 30MM, S 2.7MM CORT. SCREW 32MM, S 2.7MM CORT. SCREW 34MM, S 2.7MM CORT. SCREW 36MM, S 2.7MM CORT. SCREW 38MM, S 2.7MM CORT. SCREW 40MM, S 2.7MM CORT. SCREW 42MM, S 2.7MM CORT. SCREW 44MM, S 2.7MM CORT. SCREW 45MM, S 2.7MM CORT. SCREW 46MM, S 2.7MM CORT. SCREW 48MM, S 2.7MM CORT. SCREW 50MM, S 2.7X52 CORT SCREW/SELFTAP 2.7X54 CORT SCREW/SELFTAP 2.7X55 CORT SCREW/SELFTAP 2.7X56 CORT SCREW/SELFTAP 2.7X58 CORT SCREW/SELFTAP 2.7X60 CORT SCREW/SELFTAP 2.7X65 CORT SCREW/SELFTAP 2.7X70 CORT SCREW/SELFTAP 3.5MM CORT. SCREW 10MM LN 3.5MM CORT. SCREW 12MM LN 3.5X14 CORT SCREW 3.5MM CORT. SCREW 14MM LN 3.5X16 CORT SCREW 3.5MM CORT. SCREW 16MM LN 3.5 X 16 SHAFT SCREW 3.5X18 CORT SCREW 3.5MM CORT. SCREW 18MM LN 3.5 X 18 SHAFT SCREW 3.5MM CORT. SCREW 20MM LN 3.5 X 20 SHAFT SCREW 3.5MM CORT. SCREW 22MM LN 3.5 X 22 SHAFT SCREW 3.5MM CORT. SCREW 24MM LN 3.5 X 24 SHAFT SCREW 3.5MM CORT. SCREW 26MM LN 3.5 X 26 SHAFT SCREW 3.5MM CORT. SCREW 28MM LN 3.5 X 28 SHAFT SCREW 3.5MM CORT. SCREW 30MM LN 3.5 X 30 SHAFT SCREW 3.5MM CORT. SCREW 32MM LN 3.5 X 32 SHAFT SCREW 3.5MM CORT. SCREW 34MM LN 3.5 X 34 SHAFT SCREW 3.5MM CORT. SCREW 36MM LN 3.5 X 36 SHAFT SCREW 3.5MM CORT. SCREW 38MM LN 3.5 X 38 SHAFT SCREW 3.5MM CORT. SCREW 40MM LN 3.5 X 40 SHAFT SCREW 3.5MM CORT. SCREW 45MM LN 3.5MM CORT. SCREW 50MM LN 3.5 X 50 SHAFT SCREW 3.5MM CORT. SCREW 55MM LN 3.5MM CORT. SCREW 60MM LN 3.5MM CORT. SCREW 65MM LN 3.5MM CORT. SCREW 70MM LN 3.5MM CORT. SCREW 75MM LN 3.5MM CORT. SCREW 80MM LN 3.5X85 CORT SCREW 3.5X90 CORT SCREW 3.5X95 CORT SCREW 3.5X100 CORT SCREW 3.5X105 CORT SCREW 3.5X110 CORT SCREW 3.5X115 CORT SCREW 3.5X120 CORT SCREW 3.5X125 CORT SCREW 3.5X130 CORT SCREW 3.5X135 CORT SCREW 3.5X140 CORT SCREW 3.5X145 CORT SCREW 3.5X150 CORT SCREW 4.0 X 10 CANCELL. SCREW 4.0 X 10 PART THD CANC SC 4.0 X 12 CANCELL. SCREW 4.0 X 12 PART THD CANC SC 4.0 X 14 CANCELL. SCREW 4.0 X 14 PART THD CANC SC 4.0 X 16 CANCELL. SCREW 4.0 X 16 PART THD CANC SC 4.0 X 18 CANCELL. SCREW 4.0 X 18 PART THD CANC SC 4.0 X 20 CANCELL. SCREW 4.0 X 20 PART THD CANC SC 4.0 X 22 CANCELL. SCREW 4.0 X 22 PART THD CANC SC 4.0 X 24 CANCELL. SCREW 4.0 X 24 PART THD CANC SC 4.0 X 26 CANCELL. SCREW 4.0 X 26 PART THD CANC SC 4.0 X 28 CANCELL. SCREW 4.0 X 28 PART THD CANC SC 4.0 X 30 CANCELL. SCREW 4.0 X 30 PART THD CANC SC 4.0 X 32 CANCELL. SCREW 4.0 X 34 CANCELL. SCREW 4.0 X 35 PART THD CANC SC 4.0 X 36 CANCELL. SCREW 4.0 X 40 CANCELL. SCREW 4.0 X 40 PART THD CANC SC 4.0 X 45 CANCELL. SCREW 4.0 X 45 PART THD CANC SC 4.0 X 50 CANCELL. SCREW 4.0 X 50 PART THD CANC SC 4.0 X 55 CANCELL. SCREW 4.0 X 55 PART THD CANC SC 4.0 X 60 CANCELL. SCREW 4.0 X 60 PART THD CANC SC 4.0 X 65 CANCELL. SCREW 4.0

Reason for Recall

Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.

Details

Recalling Firm
Zimmer, Inc.
Units Affected
7,044,680 total
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom.
Location
Warsaw, IN

Recall Profile

Structured summary of the FDA Devices recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number Z-1042-2014
Date reported February 26, 2014
Date initiated October 11, 2013
Recalling firm Zimmer, Inc.
Units affected 7,044,680 total
Distribution Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portu…

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

7,044,680 total units affected — million-unit bracket.

Regional (<10K units) —
Multi-state (10K – 100K units) —
Large-scale (100K – 1M units) —
Massive (≥1M units) ✓ This recall

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

Frequently Asked Questions

What product was recalled? ▼
1.5 X 6 CORT SCREW HEX/SE 2.0 X 6 CORT SCREW HEX/SE 2.0 X 10 CORT SCREW CRUCI 2.0 X 12 CORT SCREW CRUCI 2.0 X 14 CORT SCREW CRUCI 2.0 X 16 CORT SCREW HEX/S 2.0 X 16 CORT SCREW CRUCI 2.0 X 18 CORT SCREW CRUCI 2.0 X 20 CORT SCREW CRUCI 2.0 X 26 CORT SCREW CRUCI 2.0 X 28 CORT SCREW CRUCI 2.0 X 30 CORT SCREW CRUCI 2.0 X 32 CORT SCREW CRUCI 2.0 X 34 CORT SCREW CRUCI 2.0 X 36 CORT SCREW CRUCI 2.0 X 38 CORT SCREW CRUCI 2.0 X 40 CORT SCREW CRUCI 2.0 X 42 CORT SCREW CRUCI 2.0 X 44 CORT SCREW CRUCI 2.0 X 46 CORT SCREW CRUCI 2.0 X 48 CORT SCREW CRUCI 2.0 X 50 CORT SCREW CRUCI 2.7MM CORT. SCREW 6MM, ST 2.7MM CORT. SCREW 7MM, ST 2.7MM CORT. SCREW 8MM, ST 2.7MM CORT. SCREW 9MM, ST 2.7MM CORT. SCREW 10MM, S 2.7MM CORT. SCREW 12MM, S 2.7MM CORT. SCREW 14MM, S 2.7MM CORT. SCREW 16MM, S 2.7MM CORT. SCREW 18MM, S 2.7MM CORT. SCREW 20MM, S 2.7MM CORT. SCREW 22MM, S 2.7MM CORT. SCREW 24MM, S 2.7MM CORT. SCREW 26MM, S 2.7MM CORT. SCREW 28MM, S 2.7MM CORT. SCREW 30MM, S 2.7MM CORT. SCREW 32MM, S 2.7MM CORT. SCREW 34MM, S 2.7MM CORT. SCREW 36MM, S 2.7MM CORT. SCREW 38MM, S 2.7MM CORT. SCREW 40MM, S 2.7MM CORT. SCREW 42MM, S 2.7MM CORT. SCREW 44MM, S 2.7MM CORT. SCREW 45MM, S 2.7MM CORT. SCREW 46MM, S 2.7MM CORT. SCREW 48MM, S 2.7MM CORT. SCREW 50MM, S 2.7X52 CORT SCREW/SELFTAP 2.7X54 CORT SCREW/SELFTAP 2.7X55 CORT SCREW/SELFTAP 2.7X56 CORT SCREW/SELFTAP 2.7X58 CORT SCREW/SELFTAP 2.7X60 CORT SCREW/SELFTAP 2.7X65 CORT SCREW/SELFTAP 2.7X70 CORT SCREW/SELFTAP 3.5MM CORT. SCREW 10MM LN 3.5MM CORT. SCREW 12MM LN 3.5X14 CORT SCREW 3.5MM CORT. SCREW 14MM LN 3.5X16 CORT SCREW 3.5MM CORT. SCREW 16MM LN 3.5 X 16 SHAFT SCREW 3.5X18 CORT SCREW 3.5MM CORT. SCREW 18MM LN 3.5 X 18 SHAFT SCREW 3.5MM CORT. SCREW 20MM LN 3.5 X 20 SHAFT SCREW 3.5MM CORT. SCREW 22MM LN 3.5 X 22 SHAFT SCREW 3.5MM CORT. SCREW 24MM LN 3.5 X 24 SHAFT SCREW 3.5MM CORT. SCREW 26MM LN 3.5 X 26 SHAFT SCREW 3.5MM CORT. SCREW 28MM LN 3.5 X 28 SHAFT SCREW 3.5MM CORT. SCREW 30MM LN 3.5 X 30 SHAFT SCREW 3.5MM CORT. SCREW 32MM LN 3.5 X 32 SHAFT SCREW 3.5MM CORT. SCREW 34MM LN 3.5 X 34 SHAFT SCREW 3.5MM CORT. SCREW 36MM LN 3.5 X 36 SHAFT SCREW 3.5MM CORT. SCREW 38MM LN 3.5 X 38 SHAFT SCREW 3.5MM CORT. SCREW 40MM LN 3.5 X 40 SHAFT SCREW 3.5MM CORT. SCREW 45MM LN 3.5MM CORT. SCREW 50MM LN 3.5 X 50 SHAFT SCREW 3.5MM CORT. SCREW 55MM LN 3.5MM CORT. SCREW 60MM LN 3.5MM CORT. SCREW 65MM LN 3.5MM CORT. SCREW 70MM LN 3.5MM CORT. SCREW 75MM LN 3.5MM CORT. SCREW 80MM LN 3.5X85 CORT SCREW 3.5X90 CORT SCREW 3.5X95 CORT SCREW 3.5X100 CORT SCREW 3.5X105 CORT SCREW 3.5X110 CORT SCREW 3.5X115 CORT SCREW 3.5X120 CORT SCREW 3.5X125 CORT SCREW 3.5X130 CORT SCREW 3.5X135 CORT SCREW 3.5X140 CORT SCREW 3.5X145 CORT SCREW 3.5X150 CORT SCREW 4.0 X 10 CANCELL. SCREW 4.0 X 10 PART THD CANC SC 4.0 X 12 CANCELL. SCREW 4.0 X 12 PART THD CANC SC 4.0 X 14 CANCELL. SCREW 4.0 X 14 PART THD CANC SC 4.0 X 16 CANCELL. SCREW 4.0 X 16 PART THD CANC SC 4.0 X 18 CANCELL. SCREW 4.0 X 18 PART THD CANC SC 4.0 X 20 CANCELL. SCREW 4.0 X 20 PART THD CANC SC 4.0 X 22 CANCELL. SCREW 4.0 X 22 PART THD CANC SC 4.0 X 24 CANCELL. SCREW 4.0 X 24 PART THD CANC SC 4.0 X 26 CANCELL. SCREW 4.0 X 26 PART THD CANC SC 4.0 X 28 CANCELL. SCREW 4.0 X 28 PART THD CANC SC 4.0 X 30 CANCELL. SCREW 4.0 X 30 PART THD CANC SC 4.0 X 32 CANCELL. SCREW 4.0 X 34 CANCELL. SCREW 4.0 X 35 PART THD CANC SC 4.0 X 36 CANCELL. SCREW 4.0 X 40 CANCELL. SCREW 4.0 X 40 PART THD CANC SC 4.0 X 45 CANCELL. SCREW 4.0 X 45 PART THD CANC SC 4.0 X 50 CANCELL. SCREW 4.0 X 50 PART THD CANC SC 4.0 X 55 CANCELL. SCREW 4.0 X 55 PART THD CANC SC 4.0 X 60 CANCELL. SCREW 4.0 X 60 PART THD CANC SC 4.0 X 65 CANCELL. SCREW 4.0. Recalled by Zimmer, Inc.. Units affected: 7,044,680 total.
Why was this product recalled? ▼
Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZMBV) facility in Ponce, Puerto Rico. Based on this review, it was determined that the packaging operations conducted in the Building 1 packaging operation at this facility were not properly validated. As a result, Zimmer conducted seal integrity testing to evaluate if previously packaged product from this facility met the established requirements for sterile barrier integrity. The acceptance criteria established for this testing was 99% reliability with a 90% confidence interval. These packaging tray configurations met the acceptance criteria for sterile barrier integrity of both the inner and outer trays, however, Zimmer has decided to recall all manufacturing lots that have not expired and that were sterile packaged in the ZMBV facility Building 1 packaging operations.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 26, 2014. Severity: Moderate. Recall number: Z-1042-2014.
Where was the recalled product distributed? ▼
Distribution: Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Canary Islands, China, Czech Republic, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Luxemburg, Netherlands, New Zealand, Norway, Portugal Reunion, Russian Federation, Singapore, Slovakia, Spain, Sweden, Switzerland, Turkey, Taiwan, Thailand, and United Kingdom..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1042-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
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Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

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Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).