FDAFDA · Food and drugs·Recall number Z-2147-2012
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.
Published August 15, 2012 · Recall initiated: August 12, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Linvatec Corp. dba ConMed Linvatec
- Distributor
- Nationwide Distribution, including the states of Colorado and Pennsylvania.
- Lot
- Lot #156920
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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