Recall Z-1208-2015— Biomet, Inc.

Name: FDA recall Z-1208-2015
Creator: U.S. Food and Drug Administration
Published: 2015-01-07

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2015-01-07, terminated 2015-10-22. It names one FDA 510(k) clearance: K120121. Product: Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400. Reason: The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2015-01-07
Terminated: 2015-10-22
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K120121 — COMPREHENSIVE REVERSE SHOULDER-MINI BASEPLATEBiomet, Inc.·cleared 2012-02-16

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

Comprehensive Reverse Shoulder Glenosphere Mini Baseplate 25mm with Taper Adaptor, Part Number: 010000589 Lot: 527400

Reason for recall

The taper adaptor is missing from the packaging, which may result in a delay in surgery greater than 30 minutes.

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