Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0066-2013 — "***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

U.S. FDA — Device Enforcement · United States · 2012-06-26 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0066-2013
Date of alert
2012-06-26
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Linvatec Corp. dba ConMed Linvatec
Product category
device
Product type
Devices
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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