Persona Cemented Tibial Broach Inserter/Extractor. The Persona Cemented Tibial Broach Inserter...
FDA Recall #Z-0853-2015 — Class II — December 4, 2014
Product 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.
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
Recalling Firm
Zimmer, Inc. — Warsaw, IN
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
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.
Code Information
Item: 42-5399-023-00 Lots: 62072307 62072565 62085420 62192754
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated