Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use
FDA device recall Z-0853-2015 · posted 2014-12-23 · Terminated
Recall details
- Recalling firm
- Zimmer, Inc.
- Reason for recall
- The affected lot was supplied by contract manufacturer and are potentially subject to disassociation of the magnet cover. Zimmer received one complaint indicating the magnet cover of a Persona Cemented Tibial Broach Inserter/Extractor Handle lot 62085420 was missing after broaching the tibia. Postoperative radiographs were inspected and the magnet cover was not identified. The investigation indi
- Action taken
- Notifications will be sent to the affected distributors and hospital risk managers with instructions for returning the affected product the week of December 8, 2014. Recalled product will be quarantined and returned to Zimmer Sales Representatives to be destroyed. The public contact for the recall is: Consumer Relations Call Center Zimmer, Inc. P O Box 708 Warsaw, IN 46581-0708 consumer@zimmer.com Phone: 1-800-447-5633 Fax: 574-371-8755
- Root cause
- Process design
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 83 units
- Distribution
- Distributed in the states of MN; NJ; NC; PA; AL; MI; OR; FL; OH; CO; IL and CA, and the countries of Australia, India, UAE, Germany, and Italy.
- Date initiated
- 2014-12-04
- Date posted
- 2014-12-23
- Date terminated
- 2015-05-13
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZIMMER PERSONA KNEE SYSTEM (K113369) | Zimmer, Inc. | 2012-03-27 |