Terminated

"PressFT2.6 w/ One #2 (5 metric) Hi-FiSutureNP2612009-02CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures

FDA Recall Z-0064-2013 · Posted 2012-10-15

Recalling FirmLinvatec Corp. dba ConMed Linvatec

Recall StatusTerminated

Product CodeMBI

Date Initiated2012-06-26

Date Terminated2014-10-03

Product Quantity879 units for all products in recall event

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.

Firm 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 [email protected]. For questions regarding this recall call 727-392-6464.

Root Cause

Process control

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K112965NANO SUTURE ANCHORLinvatec Corporation D/B/A Conmed Linvatec · 2011-11-02

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.