Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Persona Surgical Technique indicates that the Persona Cemented Tibial Broach Inserter/Extractor Handle is intended to broach the proximal tibia in preparation for the full seating of the tibial implant.
Enforcement
- Recall Number
- Z-0853-2015
- Event ID
- 69906
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Zimmer, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 31, 2014
- Initiation Date
- December 4, 2014
- Classification Date
- December 23, 2014
- Termination Date
- May 13, 2015
- Address
- 1800 W Center St, Warsaw, IN, 46580-2304, United States
Description
Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter/Extractor Handle is a Use sterilizable instrument intended for use In multiple TKA procedures. The Persona Surgical Technique indicates that the Persona Cemented Tibial Broach Inserter/Extractor Handle is intended to broach the proximal tibia in preparation for the full seating of the tibial implant.
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
Item: 42-5399-023-00 Lots: 62072307 62072565 62085420 62192754
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.
83 units