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
FDA Recall Z-1619-2013 · Posted 2013-07-01
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Recalling FirmLinvatec Corp. dba ConMed Linvatec
Recall StatusTerminated
Product CodeMAI
Date Initiated2013-03-06
Date Terminated2013-07-22
Product Quantity60 each of both units
Reason for Recall
Incorrect blue/white suture was used.
Firm 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 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.
Root Cause
Mixed-up of materials/components
Distribution Pattern
US Distribution including the states of FL, KY, LA, MI, NC, and NY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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