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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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.
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 · mechanical failure
See all →- SevereCanon Medical Alphenix INFX-8000C/B5 Recalled for Tabletop Shift Risk
FDA (Devices) · 2026-10-14
- ModerateLeMaitre TufTex Over-the-Wire Embolectomy Catheter Recalled for Balloon Failure
FDA (Devices) · 2026-10-14
- HighMirion Captus 4000e Thyroid Uptake System Recalled for Spring Arm Failure
FDA (Devices) · 2026-09-23
- HighIMRIS ORT300 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
- HighIMRIS ORT200 Operating Room Table Recalled for Mechanical Failure Risk
FDA (Devices) · 2026-09-02
Similar recalls
- ModerateConMed Suture Anchor Recalled for Incorrect Patient Implant Card
FDA (Devices) · 2026-09-02
- ModerateConMed Linvatec Recalls Genesys Cross FT Suture Anchors Due to Incorrect Suture Color
FDA (Devices) · 2013-07-10
- ModerateConMed Linvatec Recalls Mis-assembled CrossFT Punches for Suture Anchor Insertion
FDA (Devices) · 2012-11-07
- HighConMed Linvatec Recalls APEX Arthroscopy Tubing Sets Due to Pressure Fitting Defect
FDA (Devices) · 2013-07-17
- SevereIntegra Hallu-Fix Cannulated Screw Driver Recall Due to Tip Breakage
FDA (Devices) · 2013-07-17
- LowConMed Linvatec Recalls D3000I Surgical Drive Systems Due to Incorrect Symbology
FDA (Devices) · 2013-03-13