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.
FDA Recall Z-0853-2015 · Posted 2014-12-23
Recalling FirmZimmer, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2014-12-04
Date Terminated2015-05-13
Product Quantity83 units
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
Firm Action
Notifications will be sent to the affected distributors and hospital risk managers with instructions for returning the affected product the week of December 8, 2014. Recalled product will be quarantined and returned to Zimmer Sales Representatives to be destroyed. The public contact for the recall is: Consumer Relations Call Center
Zimmer, Inc.
P O Box 708
Warsaw, IN 46581-0708
[email protected]
Phone: 1-800-447-5633
Fax: 574-371-8755
Root Cause
Process design
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.