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Persona Trabecular Metal Tibial Plate / Persona TM… recallZ-1266-2015 · Zimmer, Inc. · initiated Jan 28, 2015

Class II Terminated All recalls posted in March 2015

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

An increase in complaints of loosening and radiolucent lines.

FDA root cause category: Under Investigation by firm

What the company is doing

Zimmer Inc. is initiating a voluntary recall of Persona Trabecular Metal Tibial following an increase in complaints of radiolucent lines and loosening. All sizes and lots of the affected devices are being removed from distribution. Urgent Medical Device Recall notices were issued to affected distributors, hospitals, and surgeons on 2/16/2015 via mail. Customers are asked to review the notification and ensure affected personnel are aware of the contents. All affected product are to be located and quarantined immediately. The Inventory Return Certification Form should be completed and returned along with the recalled product. Customers may contact the following with any questions: 1-877-946-2761 between 8:00 am and 5:00pm EST.

Recall details

Recall number
Z-1266-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Jan 28, 2015
Posted by the FDA
Mar 12, 2015
Recalling firm
Zimmer, Inc.
Quantity
11,658
Product code
MBH
FDA submissions
K121771
Distribution
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

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.

Code information (models, lots, serial numbers)

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

Other devices under the same FDA submission

135 devices cleared under K121771 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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