Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported February 26, 2014
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
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 deter…
Compiled from official public sources by the editorial team.
Verify with FDA Devices →
Zimmer, Inc. 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… - a moderate-severity action.
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… was recalled by Zimmer, Inc. in February 26, 2014. Reason: Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZM…. Check the official notice for the remedy. Verify recall #Z-1042-2014 with the FDA Devices before acting.
The recall
Zimmer, Inc. issued this moderate-severity FDA Devices recall-Zimmer recently conducted a review of all historic packaging validations at its Zimmer Manufacturing B.V. (ZM….
- Moderate
- severity level
- Class II
- classification
- February 26, 2014
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1042-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
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 list the affected scope as 7,044,680 total.
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.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
7,044,680 total
Related Recalls
6
3 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.
Recall Profile
| 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. |
| Firm location | Warsaw, IN |
| Affected scope | 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.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-1042-2014) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported February 26, 2014. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.