FDAFDA · Food and drugs·Recall number Z-0064-2013
"***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA*** To reattach soft tissue to bone in orthopedic surgical procedures
Published October 24, 2012 · Recall initiated: June 26, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Linvatec Corp. dba ConMed Linvatec
- Distributor
- 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
- Item number NP261
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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