ConMed Linvatec Recalls PressFT Sutures Due to Driver Tip Separation Risk
ConMed Linvatec is recalling PressFT 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 involves a medical device with a mechanical defect that could lead to injury during or after surgery, but no specific injuries or illnesses are reported in the source text, fitting the 'High' criteria for risk-of-harm products without reported injury.
Plain-English summary
Linvatec Corporation dba ConMed Linvatec is recalling PressFT HI-FI Sutures, including item numbers NP211, NP212, NP261, NP262, 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.
No specific instructions for consumers are provided in the source text, as these are medical devices intended for professional use in surgical settings.
The recalled product
- Product
- "***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***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 NP262
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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