Device recall
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
- Recall number
- Z-3018-2026
- Event id
- 99498
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- ConMed Corporation
- Report date
- Sep 2, 2026
- Posted
- Aug 26, 2026
- Initiated
- Jul 14, 2026
- Center classification date
- Aug 26, 2026
- Product code
- MAI
- Device type
- Fastener, Fixation, Biodegradable, Soft Tissue
- Reason
- Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
- Root cause
- Labeling design
- Quantity
- 2 units
- Code info
- UDI:10845854042472, Lot number 1513167
- Distribution
- US Nationwide distribution in the state of TX.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K101100
- Location
- Utica, NY, United States