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
This recall has been terminated (originally issued July 1, 2013).
- Recall Initiated
- March 6, 2013
- Posted
- July 1, 2013
- Terminated
- July 22, 2013
- Recall Number
- Z-1619-2013
- Quantity
- 60 each of both units
- Firm Location
- Largo, FL
- Official Source
- View on FDA website ↗
Reason for Recall
Incorrect blue/white suture was used.
Distribution
US Distribution including the states of FL, KY, LA, MI, NC, and NY.
Lot / Code Info
Product Number CFBC-4502, Lot #431437
Root Cause
Mixed-up of materials/components
Action Taken
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.