ConMed Suture Anchor Recalled for Incorrect Patient Implant Card
ConMed is recalling specific suture anchors because they may contain incorrect patient implant cards, which could lead to incorrect device identification and traceability.
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. The hazard involves incorrect documentation (patient implant card) leading to identification and traceability issues, which aligns with the rubric for minor labeling or documentation errors without reported physical injury.
Plain-English summary
ConMed Corporation is recalling the CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver (REF# CFBC-5502B). The recall involves 2 units of the 5.5mm suture anchor with two #2 (5 metric) Hi-Fi Sutures, identified by UDI 10845854042472 and Lot number 1513167.
The recall was initiated because the suture anchor may contain an incorrect patient implant card. This error may result in incorrect device identification and traceability. The affected products were distributed nationwide in the United States, specifically within the state of Texas.
Healthcare providers and patients should verify the device identification and traceability information for any implanted units. ConMed Corporation is the recalling firm responsible for this action.
The recalled product
- Product
- CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT Suture Anchor with two, #2 (5 metric) Hi-Fi Sutures Sterile
- Manufacturer
- ConMed Corporation
- Affected units
- 2
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)
- UDI:10845854042472
- Lot number 1513167
Distribution
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