FDA Device recall Z-1619-2013
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
- FDA Device
- Class II
- terminated
- Published 2013-07-10
On 2013-07-10 the FDA classified a Class II 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 by Linvatec, citing incorrect blue/white suture was used.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1619-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-03-06 |
| Published | 2013-07-10 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Linvatec |
| Distribution | FL, KY, LA, MI, NC, NY |
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
Reason
Incorrect blue/white suture was used.
Identifiers
| code_info | Product Number CFBC-4502, Lot #431437 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1619-2013%22
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