Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top Nonsteri...
FDA Device Recall #Z-2299-2014 — Class II — June 10, 2013
Recall Summary
| Recall Number | Z-2299-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | June 10, 2013 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer, Inc. |
| Location | Warsaw, IN |
| Product Type | Devices |
| Quantity | 70,986 distribution events |
Product Description
Persona (TM) The Personalized Knee System UC Tibial Articular Surface Provisional Top Nonsterile TASP UC L 3-7 CD TOP TASP UC L 4-11 EF TOP TASP UC L 7-12 GH TOP TASP UC L 9-12 J TOP
Reason for Recall
Zimmer had received complaints that reported breakage of the Persona Knee Trial Articular Surface Provisionals (TASPs). This is a retrospective recall which covers Zimmer's corrective actions taken earlier this year concerning the TASPs.
Distribution Pattern
Worldwide Distribution-USA (nationwide) including DC and Puerto Rico and the states of AK, AL, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, MA, MD, ME, MI, MN, MO, MS, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI, WY, and the countries of Australia, Canada, Germany, India, Japan, Korea, and Singapore.
Lot / Code Information
Item Numbers: 42517200410 42517200510 42517200610 42517200710 Lot Numbers: 62034570 62117742 62156315 62187322 62247350 62314721 62372409 62381836 62397160 62429190 62474906 62551390 62565048 62595853 62614781 62700416 62702297 62724349 62043548 62055681 62104368 62117743 62144794 62165545 62177246 62256282 62351288 62356244 62391228 62427419 62456268 62506003 62551338 62564355 62597762 62614786 62702292 62705808 62717332 62055682 62068376 62068378 62144795 62152727 62187323 62256283 62351289 62386419 62356275 62445931 62456266 62558584 62575757 62611087 62638672 62698749 62330130 62563854 62567418
Other Recalls from Zimmer, Inc.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-0981-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
| Z-0979-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
| Z-0973-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
| Z-0977-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
| Z-0967-2026 | Class II | Brand Name: Affixus Antegrade Femoral Nailing S... | Dec 2, 2025 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
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.