ConMed Corporation recalls CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B…
Reason for recall
Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
Affected product
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Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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 SterileUDIUDI 10845854042472Affected lot1513167
What the firm is doing
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 genesyscrossft2026@conmed.com 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 genesyscrossft2026@conmed.com
DistributionShow detailsHide
US Nationwide distribution in the state of TX.
Use of the product may cause temporary or medically reversible adverse health consequences.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-3018-2026
- FDA 510(k) clearance · K101100The device's official FDA premarket clearance record
- FDA device classification · MAIOfficial FDA classification for this device type
- CFR regulation · 21 CFR 888.3030The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find ConMed CorporationSearch for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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