Recall Z-1009-2018— Zimmer Biomet, Inc.

Name: FDA recall Z-1009-2018
Creator: U.S. Food and Drug Administration
Published: 2017-10-25

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2017-10-25, terminated 2020-05-12. It names one FDA 510(k) clearance: K143037. Product: fastener, fixation, nondegradable, soft tissue. Reason: It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-10-25
Terminated: 2020-05-12
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K143037 — SnapShot Fixation SystemBiomet Manufacturing Corp·cleared 2015-01-20

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

fastener, fixation, nondegradable, soft tissue

Reason for recall

It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.

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