Recall Z-0066-2013 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
Linvatec Corp. dba ConMed Linvatec
"***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
| Date | Oct 15, 2012 (initiated Jun 26, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 879 units for all products in recall event |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K112965 | NANO SUTURE ANCHOR Linvatec Corporation D/B/A Conmed Linvatec, Nov 2, 2011 |