Zimmer Recalls Persona Cemented Tibial Broach Inserter/Extractor Handles
Zimmer, Inc. is recalling 83 units of Persona Cemented Tibial Broach Inserter/Extractor Handles because the magnet cover may disassociate and be lost during surgery.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a component disassociating during a surgical procedure, which poses a risk of harm, but the source text does not report any injuries or illnesses.
Plain-English summary
Zimmer, Inc. is recalling 83 units of the Persona Cemented Tibial Broach Inserter/Extractor Handle. This is a use-sterilizable instrument intended for use in multiple total knee arthroplasty (TKA) procedures to broach the proximal tibia in preparation for the full seating of the tibial implant.
The recall is due to a potential defect where the magnet cover may disassociate from the handle. Zimmer received one complaint indicating that the magnet cover of a unit from lot 62085420 was missing after broaching the tibia. Postoperative radiographs were inspected, and the magnet cover was not identified. The affected lots were supplied by a contract manufacturer.
The affected units were distributed in the states of Minnesota, New Jersey, North Carolina, Pennsylvania, Alabama, Michigan, Oregon, Florida, Ohio, Colorado, Illinois, and California, as well as in Australia, India, the UAE, Germany, and Italy. The specific item number is 42-5399-023-00, and the affected lots are 62072307, 62072565, 62085420, and 62192754. Healthcare facilities should stop using these units and contact Zimmer for further instructions.
The recalled product
- 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 Insert
- Manufacturer
- Zimmer, Inc.
- Affected units
- 83
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Item: 42-5399-023-00 Lots: 62072307 62072565 62085420 62192754
Distribution
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