ConMed Linvatec Recalls PressFT HI-FI Sutures Due to Tip Separation Risk
ConMed Linvatec is recalling PressFT HI-FI Sutures because the distal tip of the driver may separate from the shaft after the implant is inserted.
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 risk-of-harm product (medical device) where the defect could cause injury, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for theoretical risk.
Plain-English summary
Linvatec Corporation dba ConMed Linvatec is recalling PressFT HI-FI Sutures, including items NP211, NP212, NP261, NP262, NP211H, and NP261H across all lot numbers. These medical devices are used to reattach soft tissue to bone in orthopedic surgical procedures.
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 source text does not report any specific injuries, illnesses, or deaths associated with this defect.
The recall covers 879 units distributed worldwide, including the United States and several international locations. Healthcare providers and consumers should stop using these specific suture items and contact the manufacturer or their medical provider for further instructions.
The recalled product
- Product
- NP211H***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 NP211H
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.
See all 6 products in this recall →Related recalls
Same manufacturer · Linvatec Corp. dba ConMed Linvatec
See all →- HighConMed Linvatec Recalls APEX Arthroscopy Tubing Sets Due to Pressure Fitting Defect
FDA (Devices) · 2013-07-17
- HighConMed Linvatec Recalls APEX Arthroscopy Tubing Sets Due to Pressure Fitting Defect
FDA (Devices) · 2013-07-17
- ModerateConMed Linvatec Recalls Genesys Cross FT Suture Anchors Due to Incorrect Suture Color
FDA (Devices) · 2013-07-10
- ModerateConMed Linvatec VP1600 HD Still Capture System Software Recall
FDA (Devices) · 2013-05-29
- LowConMed Linvatec Recalls D3000I Surgical Drive Systems Due to Incorrect Symbology
FDA (Devices) · 2013-03-13
Same hazard · device separation
See all →- CriticalAurous Centimeter Sizing Catheter Recalled for Marker Band Cracking Risk
FDA (Devices) · 2026-05-13
- SevereSmiths Medical ProPort Implantable Port Housing May Separate Due to Manufacturing Defect
FDA (Devices) · 2025-03-26
- SevereSmiths Medical ProPort Implantable Venous Ports Recalled for Separation Defect
FDA (Devices) · 2025-03-26
- SevereSmiths Medical ProPort Implantable Port Component Separation Due to Manufacturing Defect
FDA (Devices) · 2025-03-26
- SevereSmiths Medical ProPort Venous Ports Recalled for Potential Housing Separation
FDA (Devices) · 2025-03-26