Recall Z-1619-2013— Linvatec Corp. dba ConMed Linvatec

Name: FDA recall Z-1619-2013
Creator: U.S. Food and Drug Administration
Published: 2013-03-06

Class II · Terminated

Class II FDA medical device recall by Linvatec Corp. dba ConMed Linvatec, initiated 2013-03-06, terminated 2013-07-22. It names one FDA 510(k) clearance: K101100. 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..

Recalling firm: Linvatec Corp. dba ConMed Linvatec
Classification: Class II
Status: Terminated
Initiated: 2013-03-06
Terminated: 2013-07-22
Firm location: Largo, FL, United States

510(k) clearances named in this recall

1 on FDA's record

K101100 — CROSSFT OC SUTURE ANCHOR MODE CFC-4502, CFC-5502, CFC-6502, CFC-4503, CFC-5503, CFC-6503Conmed Linvatec·cleared 2010-08-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 for recall

Incorrect blue/white suture was used.

Data sourced from openFDA. This site is unofficial and independent of the FDA.