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.
This recall has been terminated (originally issued August 6, 2012).
- Recall Initiated
- August 12, 2011
- Posted
- August 6, 2012
- Terminated
- November 21, 2013
- Recall Number
- Z-2147-2012
- Quantity
- 2
- Firm Location
- Largo, FL
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide Distribution, including the states of Colorado and Pennsylvania.
Lot / Code Info
Lot #156920
Root Cause
Use error
Action Taken
The firm sent an "URGENT: Medical Device Recall Notification" letter dated August 12, 2011, to its customers after initial phone notifications. The letter describes the product, problem and actions to be taken. The customers were instructed to: 1) Immediately check their facility's inventory for the product number and lot number listed in the letter. If the product is at their facility, they were instructed to discontinue the use of the product. 2) To return the products to ConMed Linvatec for credit and return the products and Reply Form. 3) If the product was transferred to another facility, complete the Reply Form documenting the transfer of the product, and return i by mail or fax. For questions, contact 727-399-5205.