FDAFDA · Food and drugs·Recall number Z-0853-2015
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.
Published December 31, 2014 · Recall initiated: December 4, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- 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.
- Lot
- Item: 42-5399-023-00 Lots: 62072307 62072565 62085420 62192754
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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