Z-3018-2026Class II
CONMED Linvatec GENESYS CrossFT Suture Anchor with Disposable Driver REF# CFBC-5502B 5.5mm GENESYs CrossFT...
ConMed Corporation / initiated 2026-07-14 / Open, Classified / root cause: labeling and UDI
ConMed Corporation began a recall of 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... on . FDA classified it as Class II and gives the reason as "Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability". As of , the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.
Recall record
- Recall number
- Z-3018-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- 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
- Product code
- MAI Fastener, Fixation, Biodegradable, Soft Tissue
- Reason for recall
- Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
- Root cause tag
- labeling and UDI
- FDA root cause
- Labeling design
- 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]
- Quantity in commerce
- 2 units
- Distribution
- US Nationwide distribution in the state of TX.
- Product codes and lots
- UDI:10845854042472, Lot number 1513167
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-3018-2026 | Class II | Ongoing | Voluntary: Firm initiated |
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