Recall Z-0093-2021— Biomet, Inc.

Name: FDA recall Z-0093-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-02

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2020-09-02, terminated 2020-12-31. It names 2 FDA 510(k) clearances: K193373, K120121. Product: Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).. Reason: Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters.

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-09-02
Terminated: 2020-12-31
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

2 on FDA's record

K193373 — Comprehensive® Reverse ShoulderBiomet, Inc.·cleared 2020-04-15
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

Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).

Reason for recall

Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters

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