Severity
Moderate
Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIPOLAR LINER 39MM OD X 2 500104022 BIPOLAR LINER 40/41MM OD 500104026 BIPOLAR LINER 40MM OD X 2 500104222 BIPOLAR LINER 42/43 OD X 500104226 BIPOLAR LINER 42MM OD X 2 500104428 BIPOLAR LINER 44/45/46MM 500104422 BIPOLAR LINER 44MM OD X 2 500104426 BIPOLAR LINER 44MM OD X 2 500104728 BIPOLAR LINER 47/48/49MM 500104722 BIPOLAR LINER 47MM OD X 2 500104726
Reported: March 23, 2016 Initiated: January 11, 2016 #Z-1114-2016 8773 units
Zimmer Manufacturing B.V. issued this FDA Devices recall on March 23, 2016. Classified as Moderate severity (Class II). Approximately 8773 units are affected. The recall was issued because: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 …. 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-1114-2016) was formally reported on March 23, 2016, with the manufacturer initiating the action on January 11, 2016. It is classified under Moderate severity (Class II), with a current status of Terminated. Zimmer Manufacturing B.V. is listed as the recalling firm, operating out of Mercedita, PR. Federal records indicate 8773 units are affected.
The documented reason for this recall is: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile. Distribution data in the federal record shows the product reached: US Nationwide Distribution. 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 10 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
Units Affected
8773
Related Recalls
6
6 from same agency
Recall Progress (industry avg ~60%) 60.0%
Product Description
Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIPOLAR LINER 39MM OD X 2 500104022 BIPOLAR LINER 40/41MM OD 500104026 BIPOLAR LINER 40MM OD X 2 500104222 BIPOLAR LINER 42/43 OD X 500104226 BIPOLAR LINER 42MM OD X 2 500104428 BIPOLAR LINER 44/45/46MM 500104422 BIPOLAR LINER 44MM OD X 2 500104426 BIPOLAR LINER 44MM OD X 2 500104728 BIPOLAR LINER 47/48/49MM 500104722 BIPOLAR LINER 47MM OD X 2 500104726 BIPOLAR LINER 47MM OD X 2 500104732 BIPOLAR LINER 47MM OD X 3 500105028 BIPOLAR LINER 50/51/52MM 500105022 BIPOLAR LINER 50MM OD X 2 500105026 BIPOLAR LINER 50MM OD X 2 500105328 BIPOLAR LINER 53/54/55MM 500105322 BIPOLAR LINER 53MM OD X 2 500105326 BIPOLAR LINER 53MM OD X 2 500105728 BIPOLAR LINER 57/58MM OD 500105722 BIPOLAR LINER 57MM OD X 2 500106028 BIPOLAR LINER 60/62MM OD 500106828 BIPOLAR LINER 68/70MM OD 500106832 BIPOLAR LINER 68MM OD X 3 500107228 BIPOLAR LINER 72MM OD X 2 500103800 BIPOLAR SHELL 38MM OD 500103900 BIPOLAR SHELL 39MM OD 500104000 BIPOLAR SHELL 40MM OD 500104100 BIPOLAR SHELL 41MM OD 500104200 BIPOLAR SHELL 42MM OD 500104300 BIPOLAR SHELL 43MM OD 500104400 BIPOLAR SHELL 44MM OD 500104500 BIPOLAR SHELL 45MM OD 500104600 BIPOLAR SHELL 46MM OD 500104700 BIPOLAR SHELL 47MM OD 500104800 BIPOLAR SHELL 48MM OD 500104900 BIPOLAR SHELL 49MM OD 500105000 BIPOLAR SHELL 50MM OD 500105100 BIPOLAR SHELL 51MM OD 500105200 BIPOLAR SHELL 52MM OD 500105300 BIPOLAR SHELL 53MM OD 500105400 BIPOLAR SHELL 54MM OD 500105500 BIPOLAR SHELL 55MM OD 500105700 BIPOLAR SHELL 57MM OD 500105800 BIPOLAR SHELL 58MM OD 500106000 BIPOLAR SHELL 60MM OD 500106200 BIPOLAR SHELL 62MM OD 500107000 BIPOLAR SHELL 70MM OD Product Usage: For use in total or hemi hip arthroplasty
Reason for Recall
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Details
- Recalling Firm
- Zimmer Manufacturing B.V.
- Units Affected
- 8773
- Distribution
- US Nationwide Distribution
- Location
- Mercedita, PR
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1114-2016 |
| Date reported | March 23, 2016 |
| Date initiated | January 11, 2016 |
| Recalling firm | Zimmer Manufacturing B.V. |
| Units affected | 8773 |
| Distribution | US Nationwide Distribution |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
Frequently Asked Questions
What product was recalled? ▼
Product 16 consists of all product under poduct code: KWY and same usage: Item no: 500103822 BIPOLAR LINER 38MM OD X 2 500103922 BIPOLAR LINER 39MM OD X 2 500104022 BIPOLAR LINER 40/41MM OD 500104026 BIPOLAR LINER 40MM OD X 2 500104222 BIPOLAR LINER 42/43 OD X 500104226 BIPOLAR LINER 42MM OD X 2 500104428 BIPOLAR LINER 44/45/46MM 500104422 BIPOLAR LINER 44MM OD X 2 500104426 BIPOLAR LINER 44MM OD X 2 500104728 BIPOLAR LINER 47/48/49MM 500104722 BIPOLAR LINER 47MM OD X 2 500104726 BIPOLAR LINER 47MM OD X 2 500104732 BIPOLAR LINER 47MM OD X 3 500105028 BIPOLAR LINER 50/51/52MM 500105022 BIPOLAR LINER 50MM OD X 2 500105026 BIPOLAR LINER 50MM OD X 2 500105328 BIPOLAR LINER 53/54/55MM 500105322 BIPOLAR LINER 53MM OD X 2 500105326 BIPOLAR LINER 53MM OD X 2 500105728 BIPOLAR LINER 57/58MM OD 500105722 BIPOLAR LINER 57MM OD X 2 500106028 BIPOLAR LINER 60/62MM OD 500106828 BIPOLAR LINER 68/70MM OD 500106832 BIPOLAR LINER 68MM OD X 3 500107228 BIPOLAR LINER 72MM OD X 2 500103800 BIPOLAR SHELL 38MM OD 500103900 BIPOLAR SHELL 39MM OD 500104000 BIPOLAR SHELL 40MM OD 500104100 BIPOLAR SHELL 41MM OD 500104200 BIPOLAR SHELL 42MM OD 500104300 BIPOLAR SHELL 43MM OD 500104400 BIPOLAR SHELL 44MM OD 500104500 BIPOLAR SHELL 45MM OD 500104600 BIPOLAR SHELL 46MM OD 500104700 BIPOLAR SHELL 47MM OD 500104800 BIPOLAR SHELL 48MM OD 500104900 BIPOLAR SHELL 49MM OD 500105000 BIPOLAR SHELL 50MM OD 500105100 BIPOLAR SHELL 51MM OD 500105200 BIPOLAR SHELL 52MM OD 500105300 BIPOLAR SHELL 53MM OD 500105400 BIPOLAR SHELL 54MM OD 500105500 BIPOLAR SHELL 55MM OD 500105700 BIPOLAR SHELL 57MM OD 500105800 BIPOLAR SHELL 58MM OD 500106000 BIPOLAR SHELL 60MM OD 500106200 BIPOLAR SHELL 62MM OD 500107000 BIPOLAR SHELL 70MM OD Product Usage: For use in total or hemi hip arthroplasty. Recalled by Zimmer Manufacturing B.V.. Units affected: 8773.
Why was this product recalled? ▼
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 23, 2016. Severity: Moderate. Recall number: Z-1114-2016.
Where was the recalled product distributed? ▼
Distribution: US Nationwide Distribution.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-1114-2016) 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.
Recall Guides
Learn how the US recall system works and how to protect yourself and your household.
How the US Recall System Works
The three federal agencies, how recalls are initiated, and what happens next.
Understanding Recall Severity Classes
What Class I, II, and III mean and which recalls demand immediate action.
What to Do When a Product Is Recalled
Verify, claim your remedy, report injuries, and navigate the process.
How to Check If Your Products Are Recalled
Step-by-step guide to checking food, products, medications, and vehicles.
Recalled Products in Your Home
A room-by-room household audit guide for active recalls.
Most Recalled Product Categories
Rankings of highest-recall categories from FDA, CPSC, and NHTSA.
Recall Context
Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.
Related Safety Data
Explore related product safety and public health data from federal sources.
Food Safety Inspections
FDA and state food facility inspection results — violations, enforcement actions, and compliance history for food manufacturers and processors.
PlainFoodSafe →
Ingredient Safety Data
FDA food additive and ingredient safety database — regulatory status, usage limits, and safety assessments for thousands of ingredients.
PlainIngredients →
Nutrition Data
USDA nutrition facts for 2M+ food items — calories, macros, vitamins, and ingredient analysis to verify what you consume.
GetFoodFacts →
Drug Safety Information
FDA drug data for 680+ medications — interactions, alternatives, side effects, and safety information for recalled and active drugs.
PlainMeds →
Product Injury Data
CPSC emergency room injury data for 838 product categories — 7.3M NEISS records tracking real-world consumer product injuries.
PlainSafety →
Recall Checker
Search our database of 83K+ recalls by product name, brand, or recall number across all agencies.
Check Now →
Recall Radar
Live feed of the latest recalls across FDA, CPSC, NHTSA, and USDA — filter by agency and severity.
View Radar →
Nearby Recalls in This Category
Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.
FDA Devices Moderate
Endo-Model Replacement Plateau; Item Number: 15-0027/11;
Waldemar Link GmbH & Co. KG (Mfg Site) · 2026-03-18
FDA Devices Low
Penner Pacific Bathing Spa, Model Numbers 360020-1P
Penner Patient Care, Inc. · 2026-03-18
FDA Devices Moderate
GEM Premier 5000 PAK, Part No. 00055360004.
Instrumentation Laboratory · 2026-03-18
FDA Devices Moderate
CHEMISTRY ANALYZER AU5800, REF: B96697, B96698, B23279, B23280, B23281
Beckman Coulter Mishima K.K. · 2026-03-18
FDA Devices Critical
Owner's Booklets and Instructions for Use that are used with the following blood glucose measurement devices. Descript…
Trividia Health, Inc. · 2026-03-18
Compare this recall with Endo-Model Replacement Plateau; Item Number: 15-0027/11; →
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)
- Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)
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.
Read our methodology — how this data is sourced, computed, and verified.
All federal data sources used on this page
- U.S. Census Bureau ACS — demographic + housing + income data. census.gov/programs-surveys/acs
- BLS Occupational Employment and Wage Statistics (OEWS) — wage + employment by occupation. bls.gov/oes
- BEA Regional Economic Accounts — GDP + personal income by state/metro. bea.gov/data/regional
- U.S. Census Bureau County Business Patterns — establishment + employment by industry. census.gov/cbp
- IRS Statistics of Income (SOI) — tax-return aggregate data. irs.gov/statistics
- data.gov — U.S. federal open-data portal — discovery layer for additional federal sources. data.gov
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).