FDA Devices recall · Reported March 23, 2016
Product 49 consists of all product under product code: JWH and same usage: Item no: 597206529 NEXGEN ALL-POLY PATELLA, 597206532 NEXGEN ALL-POLY PATELLA, 597206535 NEXGEN ALL-POLY PATELLA, 597206538 NEXGEN ALL-POLY PATELLA, 597206541 NEXGEN ALL-POLY PATELLA, 598801713 NEXGEN CEMENTED STEM EXT 598801813 NEXGEN CEMENTED STEM EXT 598801913 NEXGEN CEMENTED STEM EXT 598801610 NEXGEN FLUTED STEM EXT, 1 598801611 NEXGEN FLUTED STEM EXT, 1 598801612 NEXGEN FLUTED STEM EXT, 1 598801613 NEX
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.
Zimmer Manufacturing B.v. recalled Product 49 consists of all product under product code: JWH and same usage: Item no: 5… - a moderate-severity action.
Product 49 consists of all product under product code: JWH and same usage: Item no: 5… was recalled by Zimmer Manufacturing B.v. in March 23, 2016. Reason: As a result of the insufficient sealer calibration data for product packaged in firm's Building II between Au…. Check the official notice for the remedy. Verify recall #Z-1147-2016 with the FDA Devices before acting.
The recall
Zimmer Manufacturing B.v. issued this moderate-severity FDA Devices recall-As a result of the insufficient sealer calibration data for product packaged in firm's Building II between Au….
- Moderate
- severity level
- 53K units
- affected scope
- Class II
- classification
- March 23, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-1147-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 6 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 - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.
Product description
Product 49 consists of all product under product code: JWH and same usage: Item no: 597206529 NEXGEN ALL-POLY PATELLA, 597206532 NEXGEN ALL-POLY PATELLA, 597206535 NEXGEN ALL-POLY PATELLA, 597206538 NEXGEN ALL-POLY PATELLA, 597206541 NEXGEN ALL-POLY PATELLA, 598801713 NEXGEN CEMENTED STEM EXT 598801813 NEXGEN CEMENTED STEM EXT 598801913 NEXGEN CEMENTED STEM EXT 598801610 NEXGEN FLUTED STEM EXT, 1 598801611 NEXGEN FLUTED STEM EXT, 1 598801612 NEXGEN FLUTED STEM EXT, 1 598801613 NEXGEN FLUTED STEM EXT, 1 598801614 NEXGEN FLUTED STEM EXT, 1 598801615 NEXGEN FLUTED STEM EXT, 1 598801616 NEXGEN FLUTED STEM EXT, 1 598801618 NEXGEN FLUTED STEM EXT, 1 598801619 NEXGEN FLUTED STEM EXT, 1 598801620 NEXGEN FLUTED STEM EXT, 2 598801622 NEXGEN FLUTED STEM EXT, 2 598801624 NEXGEN FLUTED STEM EXT, 2 597206126 NEXGEN MICRO ALL-POLY PAT 597206129 NEXGEN MICRO ALL-POLY PAT 597206132 NEXGEN MICRO ALL-POLY PAT 597206135 NEXGEN MICRO ALL-POLY PAT for use in total knee 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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-1147-2016 |
| Date reported | March 23, 2016 |
| Date initiated | January 11, 2016 |
| Recalling firm | Zimmer Manufacturing B.v. |
| Firm location | Mercedita, PR |
| Affected scope | 53338 |
| Distribution | US Nationwide Distribution |
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-1147-2016) 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.
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Nationwide recalls with similar severity or category timing
Drug and device notices outside this firm and state, matched by severity timing and product category.
Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
Same product category, closest by report date among other firms and states (deduped against the severity set).
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Methodology · Corrections · Archive as of August 2026