NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
This recall has been terminated (originally issued October 15, 2012).
- Recall Initiated
- June 26, 2012
- Posted
- October 15, 2012
- Terminated
- October 3, 2014
- Recall Number
- Z-0068-2013
- Quantity
- 879 units for all products in recall event
- Firm Location
- Largo, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Linvatec Corporation dba ConMed Linvatec in Largo, FL is recalling PressFT HI-FI Sutures (items NP211, NP212, NP261, NP262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip of the driver to become separated from the driver shaft after successful insertion of the implant.
Distribution
Worldwide Distribution - USA including AZ, CA, CO, FL, GA, LA, MA, ME, MI, MN, NJ, NM, NY, PA, TX, UT, and WA. Internationally to BE, CA, ES, MY, NZ and PL
Lot / Code Info
Item number NP211H
Root Cause
Process control
Action Taken
ConMed Linvatec sent an Urgent Medical Device Recall Notification letter on June 26, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately check their facility for the recalled products, segregate them for return to ConMed Linvatec. The customers were also told to return the REPLY FORM to the Regulatory Department at the firm. For questions customers were instructed to call 800-237-0169 or email at Custserv1@linvatec.com. For questions regarding this recall call 727-392-6464.