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Open, Classified

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

FDA Recall Z-3018-2026 · Posted 2026-08-26

Recalling FirmConMed Corporation
Recall StatusOpen, Classified
Product CodeMAI
Date Initiated2026-07-14
Product Quantity2 units

Reason for Recall

Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.

Firm Action

On July 14, 2026, Conmed Corporation issued an Urgent Medical Device Correction to affected consignees via email: Conmed Corporation asked consignees to take the following actions: 1. Replace the Patient Implant Card with the corrected Patient Implant Card included with this notification. 2.Retain the corrected Patient Implant Card for your records and discard the incorrect PIC to ensure accurate device traceability and recordkeeping. 3. If you have provided these devices to other facilities or distributors, or you are a distributor, please forward this information as appropriate. 4. Review your inventory for any of the devices listed in Table 1. We ask that you contact all departments within your facility and any other facilities within your organization that may have received affected products. 5. Devices that have been implanted, please follow hospital protocols for identifying and notifying affected patients/users as appropriate. For devices that have not been implanted, please follow your hospital protocols to review and update the Patient Implant Card (PIC) records accordingly. 6. If you have inventory of any of the devices listed in Table 1, please complete the medical device recall response form (Attachment I) and return acknowledgement via email to [email protected] 7. For devices that have been implanted, please follow hospital protocols for identifying and notifying affected patients/users as appropriate. For devices that have not been implanted, please follow your hospital protocols to review and update the Patient Implant Card (PIC) records accordingly. 8. If you have inventory of any of the devices listed in Table 1, please complete the medical device recall response form (Attachment I) and return acknowledgement via email to [email protected]

Root Cause

Labeling design

Distribution Pattern

US Nationwide distribution in the state of TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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