ConMed Linvatec Recalls PressFT HI-FI Sutures Due to Driver Tip Separation
ConMed Linvatec is recalling PressFT HI-FI Sutures because the driver tip may separate from the shaft after the implant is inserted.
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 involves a medical device defect that poses a risk of harm (foreign object retention) but does not report specific injuries or fatalities, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
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. This defect could leave a foreign object in the patient or compromise the surgical procedure.
The affected products were distributed worldwide, including in the United States and several international locations. Healthcare providers and patients should contact ConMed Linvatec for further instructions on how to manage the recalled devices.
The recalled product
- Product
- "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***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 NP212
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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