Recall Z-0853-2015— Zimmer, Inc.

Name: FDA recall Z-0853-2015
Creator: U.S. Food and Drug Administration
Published: 2014-12-04

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2014-12-04, terminated 2015-05-13. It names one FDA 510(k) clearance: K113369. Product: 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: 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.
Classification: Class II
Status: Terminated
Initiated: 2014-12-04
Terminated: 2015-05-13
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K113369 — ZIMMER PERSONA KNEE SYSTEMZimmer, Inc.·cleared 2012-03-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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

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