GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI… recallZ-1619-2013 · Linvatec Corp. dba ConMed Linvatec · initiated Mar 6, 2013
Class II Terminated All recalls posted in July 2013
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Linvatec Corp. dba ConMed Linvatec or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect blue/white suture was used.
FDA root cause category: Mixed-up of materials/components
What the company is doing
ConMed Linvatec sent an "URGENT: Medical Device Recall Notification" letter by FedEx next day delivery on March 6, 2013, to notify all direct consignees of the recall. If the account no longer had the product in possess, they were asked to respond via a reply form or to contact ConMed Linvatec Customer Service to obtain a Service Request number for return and credit of unused unopened product. All returned product for this action would be identified, segregated and quarantined per the firm's procedures. Any returned product not part of the recall will be dispositioned in accordance with the firm's procedures. Please accept our sincere apology for any inconvenience this action may have caused . Should you have any questions please contact our Customer Service department at (800) 237-0169.
Recall details
- Recall number
- Z-1619-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 6, 2013
- Posted by the FDA
- Jul 1, 2013
- Recalling firm
- Linvatec Corp. dba ConMed Linvatec
- Quantity
- 60 each of both units
- Product code
- MAI
- FDA submissions
- K101100
- Distribution
- US Distribution including the states of FL, KY, LA, MI, NC, and NY.
Product description
GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO CONMED LINVATEC REF CFBC-4502. Reattachment of soft tissue to bone in orthopedic surgical procedures
Code information (models, lots, serial numbers)
Product Number CFBC-4502, Lot #431437
Other devices under the same FDA submission
5 devices cleared under K101100 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- GENESYS CrossFT, Hi-Fi CFBC-5502BConmed Corporation · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 recall1 report
- GENESYS CrossFT, Hi-Fi CFBC-5502Conmed Corporation · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 report
- GENESYS CROSSFT, HI-FI, LINVATEC SRS CFBC-5502NConmed Corporation · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 report
- GENESYS CrossFT, Hi-Fi CFBC-6502BConmed Corporation · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 report
- GENESYS CrossFT, Hi-Fi CFBC-5503BConmed Corporation · FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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