ConMed Linvatec Recalls Press FT HI-FI Sutures Due to Driver Tip Separation
ConMed Linvatec is recalling Press FT HI-FI Sutures because the driver tip may separate from the shaft after implant insertion.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a mechanical failure of a surgical instrument during a procedure, which poses a risk of harm even though specific injuries are not reported in the source text.
Plain-English summary
Linvatec Corporation DBA ConMed Linvatec is recalling Press FT HI-FI Sutures, including items NP 211, NP 212, NP 261, NP 262, NP211H, and NP261H across all lot numbers. The recall is due to the potential for the distal tip of the driver to become separated from the driver shaft after the successful insertion of the implant.
The affected products are used to reattach soft tissue to bone in orthopedic surgical procedures. The recall covers 879 units distributed worldwide, including in the United States and internationally to Belgium, Canada, Spain, Malaysia, New Zealand, and Poland.
Healthcare providers should stop using the affected suture products and contact the manufacturer for instructions on how to return or dispose of the devices.
The recalled product
- Product
- "***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
- Manufacturer
- Linvatec Corp. dba ConMed Linvatec
- Affected units
- 879
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Item number NP261H
Distribution
Part of a larger recall action
This product is one of 6 recalled by Linvatec Corp. dba ConMed Linvatec under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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