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Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, ...

FDA Device Recall #Z-1266-2015 — Class II — January 28, 2015

Recall Summary

Recall Number Z-1266-2015
Classification Class II — Moderate risk
Date Initiated January 28, 2015
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Zimmer, Inc.
Location Warsaw, IN
Product Type Devices
Quantity 11,658

Product Description

Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer For use in either posterior cruciate retaining or sacrificing surgical procedures.

Reason for Recall

An increase in complaints of loosening and radiolucent lines.

Distribution Pattern

Worldwide Distribution -- US, including the states of AK, AL, AZ, CA, CO, FL, IL, IN, KS, MA, MI, MN, MO, NC, NJ, NY, OH, OK, PA, TN, TX, UT, VA, WA, and WI; Foreign:Canada, Australia, New Zealand, Korea, Austria, Belgium, Germany, Italy, Luxembourg, Netherlands, South Africa, Sweden, Switzerland, and United Arab Emirates. DOD/VA: HOSPITAL- VA MAINE HLTCR SYTM (402) VA MROC (402) ATTN: PROSTHETICS DEPT TOGUS ME 04330 207-672-9425 HOSPITAL VA MED CTR (438) 2501 W 22 SIOUX FALLS, SD 57105 605-336-8922 HOSPITAL VA MED CTR (509)1 FREEDOM WAY AUGUSTA , GA 30904 706-721-6892 HOSPITAL VA MED CTR (521) 700 S 19TH ST, BIRMINGHAM, AL 35233 378-962-1599 HOSPITAL VA MED CTR (523) 1400 VFW PARKWAY, WEST ROXBURY, MA 02132 617-862-5977 HOSPITAL VA MED CTR (528) 3495 BAILEY AVENUE BUFFALO, NY 14215 716-898-6922 HOSPITAL VA MED CTR (552) 4100 WEST 3RD STREET BLDG # 330 RECEIVING, DAYTON, OH 45428 937-226-5987 HOSPITAL VA MED CTR (583), 1481 WEST 10TH STREET INDIANAPOLIS, IN 46202 317-267-8765 HOSPITAL VA MED CTR (595) 1700 SOUTH LINCOLN AVENUE, LEBANON, PA 17042 717-272-6621 HOSPITAL VA MED CTR (657) 915 N GRAND BLVD, ST LOUIS, MO 63106 314-652-4100 HOSPITAL VA MED CTR (664) 350 LA JOLLA VILLAGE DR SAN DIEGO, CA 92161 858-552-8585 HOSPITAL VA MED CTR (693) 1111 EAST END BOULEVARD, WILKES BARRE, PA 18711 717-824-3521 HOSPITAL VA SNHCS (654/118) 975 KIRMAN AVENUE RENO NV 89502 702-597-1699

Lot / Code Information

All lots and sizes; Sizes C-J Left and Right.

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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.

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