Recall Z-0253-2018— ConMed Corporation

Name: FDA recall Z-0253-2018
Creator: U.S. Food and Drug Administration
Published: 2017-04-17

Class II · Terminated

Class II FDA medical device recall by ConMed Corporation, initiated 2017-04-17, terminated 2021-08-31. It names one FDA 510(k) clearance: K091549. Product: Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.. Reason: Manufactured with the incorrect anchor outer body.

Recalling firm: ConMed Corporation
Classification: Class II
Status: Terminated
Initiated: 2017-04-17
Terminated: 2021-08-31
Firm location: Utica, NY, United States

510(k) clearances named in this recall

1 on FDA's record

K091549 — CONMED LINVATEC SOFT TISSUE TO BONE SYSTEMLinvatec Corp.·cleared 2009-06-23

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

Nonabsorbable suture anchor system intended to reattach soft tissue to bone in orthopedic surgical procedures may be used in either arthroscopic or open surgical procedures.

Reason for recall

Manufactured with the incorrect anchor outer body

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