Z-0065-2013 Class II Terminated
FDA device recall Z-0065-2013 was initiated by Linvatec Corp. dba ConMed Linvatec on June 26, 2012 and is designated Class II. Reason for recall: Linvatec Corporation DBA ConMed Linvatec in Largo, FL is recalling Press FT HI-FI Sutures (items NP 211, NP 212, NP 261, NP 262, NP211H, NP261H-all lot numbers) due to the potential for the distal tip… The recall status is terminated (terminated October 3, 2014). Affected quantity: 879 units for all products in recall event.
Recall Details
- Product Type
- Devices
- Report Date
- October 24, 2012
- Initiation Date
- June 26, 2012
- Termination Date
- October 3, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 879 units for all products in recall event
Product Description
"***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***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 Press FT HI-FI Sutures (items NP 211, NP 212, NP 261, NP 262, 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.
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
Code Information
Item number NP261H