Persona Trabecular Metal Tibial Plate / Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncem
FDA device recall Z-1266-2015 · posted 2015-03-12 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- An increase in complaints of loosening and radiolucent lines.
- Action taken
- 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.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- MBH
- Quantity affected
- 11,658
- 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, Ko
- Date initiated
- 2015-01-28
- Date posted
- 2015-03-12
- Date terminated
- 2018-03-13
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMER PERSONA THE PERSONALIZED KNEE SYSTEM (K121771) | Zimmer, Inc. | 2012-11-07 |