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Recall Observatory FDA recall evidence

Device 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.

Z-0853-2015

December 04, 2014

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 69906
Status
Terminated
Classification
Class II
Quantity
83 units
Official record key
device-enforcement:Z-0853-2015

Official wording

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

Code information: Item: 42-5399-023-00 Lots: 62072307 62072565 62085420 62192754

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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

Field note

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