FDA-Device2013-07-10Class II

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

Linvatec Corp. dba ConMed Linvatec
Hazard

Incorrect blue/white suture was used.

Sold states
US Distribution including the states of FL, KY, LA, MI, NC, and NY.
Affected count
60 each of both units
Manufactured in
11311 Concept Blvd, N/A, Largo, FL, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1619-2013

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