Recall Z-0068-2013— Linvatec Corp. dba ConMed Linvatec

Name: FDA recall Z-0068-2013
Creator: U.S. Food and Drug Administration
Published: 2012-06-26

Class II · Terminated

Class II FDA medical device recall by Linvatec Corp. dba ConMed Linvatec, initiated 2012-06-26, terminated 2014-10-03. It names one FDA 510(k) clearance: K112965. Product: NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures. 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..

Recalling firm: Linvatec Corp. dba ConMed Linvatec
Classification: Class II
Status: Terminated
Initiated: 2012-06-26
Terminated: 2014-10-03
Firm location: Largo, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K112965 — NANO SUTURE ANCHORLinvatec Corporation D/B/A Conmed Linvatec·cleared 2011-11-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.