Recall Z-1619-2013 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
Linvatec Corp. dba ConMed Linvatec
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
| Date | Jul 1, 2013 (initiated Mar 6, 2013) |
| Status | Terminated |
| Reason | Incorrect blue/white suture was used. |
| Root cause | Mixed-up of materials/components |
| Action | 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 |
| Quantity | 60 each of both units |
| Distribution | US Distribution including the states of FL, KY, LA, MI, NC, and NY. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K101100 | CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503 Conmed Linvatec, Aug 26, 2010 |