Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized u...
FDA Device Recall #Z-2737-2014 — Class II — September 9, 2014
Recall Summary
| Recall Number | Z-2737-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 9, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Zimmer, Inc. |
| Location | Warsaw, IN |
| Product Type | Devices |
| Quantity | 16,380 units |
Product Description
Persona The Personalized Knee System 2.5 mm Female Screw 48 mm Length Sterile Qty-2. Sterilized using irradiation, single use.
Reason for Recall
The Persona 48mm X 2.5mm Female Screw is being recalled due to potential use of the screw in cortical bone, and corresponding stripping of the 2.5mm Persona Hex Driver.
Distribution Pattern
Nationwide Distribution including the states of : HI, CA, UT, NY, OH, IN, AL, FL, GA, WI, IA, MN, NE, SD, NJ, PA, ND, IL, MO, VA, MD, NC, MI, OR, WA, KS, KY, TN, WV, OK, CT, MA, ME, AZ, NM, TX, LA, ID, CO, MT, UT, NV and AK., and Internationally to Singapore, Japan, Germany and Canada.
Lot / Code Information
Lot Numbers: 62155015 62165014 62165015 62165016 62165017 62165018 62182742 62182743 62188282 62188283 62191355 62191361 62191366 62191372 62210290 62210291 62227943 62230668 62230669 62230670 62230671 62230672 62230673 62230674 62230675 62230676 62255591 62255592 62255593 62255594 62255595 62255596 62255597 62255598 62283576 62283577 62283578 62288220 62288221 62288222 62288223 62288224 62305911 62305912 62305913 62305914 62327983 62327985 62327987 62327988 62327989 62348078 62348079 62348080 62348091 62348092 62348095 62379888 62379889 62379890 62379891 62391801 62391802 62391803 62391804 62391805 62391807 62391808 62408432 62408438 62408439 62408440 62408441 62417035 62417036 62417037 62444920 62444921 62444922 62444925 62453583 62453584 62453585 62475432 62475433 62475434 62475435
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.