ConMed Linvatec Recalls Genesys Cross FT Suture Anchors Due to Incorrect Suture Color
ConMed Linvatec is recalling 60 units of Genesys Cross FT Suture Anchors because incorrect blue/white sutures were used instead of the specified type.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a manufacturing error (incorrect suture color) without reported adverse health consequences, fitting the criteria for a moderate severity score.
Plain-English summary
ConMed Linvatec is recalling 60 units of the Genesys Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Sutures, product number CFBC-4502, lot number 431437. The recall was initiated because incorrect blue/white sutures were used in the manufacturing of these devices.
The affected products are sterile, ethylene oxide sterilized, and intended for the reattachment of soft tissue to bone in orthopedic surgical procedures. The recall covers units distributed in the United States, specifically in the states of Florida, Kentucky, Louisiana, Michigan, North Carolina, and New York.
Healthcare providers and facilities that have received these specific units should stop using them and contact ConMed Linvatec for further instructions on return or disposal. Patients who have already had these devices implanted should contact their healthcare provider if they have concerns.
The recalled product
- Product
- GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures
- Manufacturer
- Linvatec Corp. dba ConMed Linvatec
- Affected units
- 60
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 (2)
- Product Number CFBC-4502
- Lot #431437
Distribution
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