Z-1619-2013Class II

GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO...

Name: Z-1619-2013 GENESYS Cross FT Suture Anchor with Two #2 (5 metric) Hi-FI Registered Trade Mark Sutures Rx Only STERILE EO...
Creator: Linvatec Corp. dba ConMed Linvatec
Published: 2013-03-06
License: https://open.fda.gov/license/

Linvatec Corporation / initiated 2013-03-06 / Terminated

FDA source

Linvatec Corp. dba ConMed Linvatec began a recall of 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... on 2013-03-06. FDA classified it as Class II and gives the reason as "Incorrect blue/white suture was used". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1619-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-06
Posted: 2013-07-01
Terminated: 2013-07-22
Recalling firm: Linvatec Corporation
Product: 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
Product code: MAI Fastener, Fixation, Biodegradable, Soft Tissue
Reason for recall: Incorrect blue/white suture was used.
FDA 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 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.
Quantity in commerce: 60 each of both units
Distribution: US Distribution including the states of FL, KY, LA, MI, NC, and NY.
Product codes and lots: Product Number CFBC-4502, Lot #431437

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1619-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1619-2013	Class II	Terminated	Voluntary: Firm initiated	2013-07-10	2013-07-01

Product code MAI

K101100Class IICrossft Oc Suture Anchor Mode Cfc-4502, Cfc-5502, Cfc-6502, Cfc-4503, Cfc-5503, Cfc-6503Conmed Linvatec / cleared 2010-08-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)