ConMed Linvatec GENESYS CrossFT Suture Anchor Recall
The recall covers the CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF CFBC-5502B (5.5mm) and two Hi-Fi Sutures. The suture anchor may contain an incorrect patient implant card, which may result in incorrect device identification and traceability. Distribution was nationwide in the United States, with TX included; Recall numbers are UDI 10845854042472 and Lot 1513167.
| Brand | ConMed Corporation |
|---|---|
| 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 |
| Reason | Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability. |
| Severity | moderate |
| Units affected | 2 |
| Distribution | US Nationwide distribution in the state of TX. |
| Agency | FDA |
WHAT YOU SHOULD DO
- Do not use or implant the recalled CONMED Linvatec GENESYS CrossFT Suture Anchor.
- Contact your surgeon or hospital for guidance on return or replacement options.
- Preserve the product and packaging and follow facility instructions for removal or return.
- Monitor the FDA and manufacturer updates for additional instructions and support.
How to identify the recalled item
| Lot / date codes | UDI:10845854042472, Lot number 1513167 |
|---|---|
| Lot / date codes | UDI:10845854042472, Lot number 1513167 |
These are the identifiers FDA published for this recall. Most recall notices list no UPC or model number at all — if the code on your item is not shown here, that does not mean the item is excluded. Check the official notice, or contact the company.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.