Product 48 consists of all product under product code: JWH and same usage: Item no: 597206526...
FDA Device Recall #Z-1146-2016 — Class II — January 11, 2016
Recall Summary
| Recall Number | Z-1146-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | January 11, 2016 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer Manufacturing B.V. |
| Location | Mercedita, PR |
| Product Type | Devices |
Product Description
Product 48 consists of all product under product code: JWH and same usage: Item no: 597206526 NEXGEN ALL-POLY PATELLA, 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.
Distribution Pattern
US Nationwide Distribution
Lot / Code Information
lot no.: 61873094 61895696 61905916 61905918 61905920 61919766 61919767 61919768 61956249 61956250 61981202 61981204 61999375 62027331 62060784 62074467 62074469 62096750 62096751 62133740 62164984 62168517 62171693 62171694 62171696 62174936 62205101 62213332 62213333 62220943 62345691 62345692 62345693 62345694 62352447 62352450
Other Recalls from Zimmer Manufacturing B.V.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1676-2016 | Class II | Periarticular plating system, cancellous bone s... | May 4, 2016 |
| Z-1678-2016 | Class II | M/DN Intramedullary Fixation 4.2 mm Diameter Co... | May 4, 2016 |
| Z-1677-2016 | Class II | Zimmer Plates and Screws (ZPS) 4.0 mm Cancell... | May 4, 2016 |
| Z-1684-2016 | Class II | Trilogy self-tapping bone screw Bone screw 4.... | May 4, 2016 |
| Z-1682-2016 | Class II | VersaFx Femoral Fixation System Hex head comp... | May 4, 2016 |
Frequently Asked Questions
Sterility recalls for medical devices vary in severity. If you have already had a procedure using a potentially non-sterile device, contact your healthcare provider immediately — you may need monitoring for signs of infection. Symptoms to watch for include fever, redness or swelling at the surgical site, unusual pain, or discharge. For devices that have not yet been used, they should be quarantined and returned to the manufacturer per the recall notice. Non-sterile implants can cause serious infections; early detection and treatment are critical.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.