Recall Z-0972-2019— Zimmer Biomet, Inc.

Name: FDA recall Z-0972-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-21

Class II · Terminated

Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2018-12-21, terminated 2020-05-06. It names one FDA 510(k) clearance: K120121. Product: Comprehensive Reverse Shoulder System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.. Reason: The product was potentially being packaged without a taper adapter..

Recalling firm: Zimmer Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-12-21
Terminated: 2020-05-06
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 System Glenosphere Mini Baseplate with Taper Adapter, Model Number 010000589 Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.

Reason for recall

The product was potentially being packaged without a taper adapter.

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