CLASS II ONGOING Device recall · Reported 2 Sep 2026 · FDA Enforcement Report
Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled
ConMed is recalling Conmed Linvatec Genesys CrossFT Suture Anchor with Disposable Driver, distributed nationwide in the US. The recall was initiated on 14 Jul 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-3018-2026
- FDA event ID
- 99498
- Recalling firm
- ConMed, Utica, NY
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Jul 2026
- FDA classified
- 26 Aug 2026
- Reported
- 2 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Sterility
- Device type
- Surgical Instruments
Timeline
| 14 Jul 2026 | Recall initiated by company | |
| 26 Aug 2026 | Classified by FDA | +43 days |
| 2 Sep 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
US Nationwide distribution in the state of TX.
Questions about this recall
Is Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled?
Yes. ConMed recalled Linvatec Genesys CrossFT Suture Anchor with Disposable Driver on 14 Jul 2026. The recall is Class II and its status is Ongoing. Recall number Z-3018-2026.
Why was it recalled?
Suture anchor may contain incorrect patient implant card which may result in incorrect device identification and traceability.
Which lots are affected?
UDI:10845854042472, Lot number 1513167
Where was it sold?
US Nationwide distribution in the state of TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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