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.
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 involves a risk-of-harm product (surgical device defect) where no specific injuries or illnesses have been reported in the source text, fitting the 'High' severity criteria.
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. These medical devices are used to reattach soft tissue to bone in orthopedic surgical procedures.
The recall is being conducted due to a potential defect where the distal tip of the driver may become separated from the driver shaft after the implant has been successfully inserted. This issue could affect the integrity of the surgical procedure.
The recall involves 879 units distributed worldwide, including the United States and several international locations. Healthcare providers and facilities should check their inventory for these specific item numbers and stop using them if found.
The recalled product
- Product
- "***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***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 NP261
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
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