FDA Enforcement
Class II
Terminated
"***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
Recall: Z-0066-2013
·
Reported October 24, 2012
Enforcement
- Recall Number
- Z-0066-2013
- Event ID
- 63115
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Linvatec Corp. dba ConMed Linvatec
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- October 24, 2012
- Initiation Date
- June 26, 2012
- Classification Date
- October 15, 2012
- Termination Date
- October 3, 2014
- Address
- 11311 Concept Blvd, N/A, Largo, FL, 33773-4908, United States
Description
"***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
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.
Code Info
Item number NP212
Distribution
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
Quantity
879 units for all products in recall event