Recall Z-1079-2014— Zimmer, Inc.

Name: FDA recall Z-1079-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-17

Class II · Terminated

Class II FDA medical device recall by Zimmer, Inc., initiated 2013-10-17, terminated 2014-09-12. It names one FDA 510(k) clearance: K052906. Product: Trabecular Metal" Reverse Shoulder System. Reason: As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and released a video to provide additional instructions to users on how to properly assemble the Glenosphere to the Baseplate..

Recalling firm: Zimmer, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-17
Terminated: 2014-09-12
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K052906 — ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEMZimmer, Inc.·cleared 2005-12-19

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

Trabecular Metal" Reverse Shoulder System

Reason for recall

As a result of complaints for disassociation of the TM Reverse Glenosphere from the Baseplate, Zimmer updated the related surgical technique and released a video to provide additional instructions to users on how to properly assemble the Glenosphere to the Baseplate.

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