CrossFT Punch, Product Number PFT-45M — recall Z-2147-2012
U.S. FDA — Device Enforcement · United States · 2011-08-12 · Class II
As described by U.S. FDA — Device Enforcement: CrossFT Punch, Product Number PFT-45M. Manufacturer: CONMED LINVATEC. The intended use is to create a hole to facilitate insertion of the CrossFT suture anchor into bone.
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Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Nationwide Distribution, including the states of Colorado and Pennsylvania.
Reported risk: ConMed Linvatec recalled lot number #156920, PFT-45M, CrossFT Punch because there is a possibility that the device was etched incorrectly listing the item number as PFT-00M and includes incorrect depth lines for insertion.
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