Recall Z-1739-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-1739-2018
Creator: U.S. Food and Drug Administration
Published: 2018-03-28

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-03-28, terminated 2019-03-29. It names one FDA 510(k) clearance: K982497. Product: Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.. Reason: Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-03-28
Terminated: 2019-03-29
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K982497 — ARTHROTEK INTERFERENCE SCREWBiomet, Inc.·cleared 1998-10-16

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

Gentle Threads, Interference Screw; Model No. 905615, for soft tissue reattachment procedures in the ankle/foot and knee.

Reason for recall

Specific lots of the device were overexposed during EtO sterilization. This may lead to revision due to infection from loss of sterile barrier during over-exposure cycle.

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