Recall Z-0619-2021— Biomet, Inc.

Name: FDA recall Z-0619-2021
Creator: U.S. Food and Drug Administration
Published: 2020-11-25

Class II · Terminated

Class II FDA medical device recall by Biomet, Inc., initiated 2020-11-25, terminated 2024-05-08. It names 3 FDA 510(k) clearances: K193373, K130390, K132239. Product: Comprehensive Reverse Shoulder System, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthroplasty and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff The patient must anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.. Reason: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device..

Recalling firm: Biomet, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-11-25
Terminated: 2024-05-08
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

3 on FDA's record

K193373 — Comprehensive® Reverse ShoulderBiomet, Inc.·cleared 2020-04-15
K130390 — COMPREHENSIVE CONVERTIBLE GLENOIDBiomet Manufacturing, Inc.·cleared 2013-10-09
K132239 — COMPREHENSIVE REVERSE SHOULDER SCREWSBiomet Manufacturing Corp·cleared 2013-09-06

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, Item numbers 115394, 115395, 115396, 115398, 180550, 180551, 180552, 180553, 180554, 180555, 180556, 180557, 180558, 180559, 180560, 180562 - Product Usage: indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthroplasty and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff The patient must anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.

Reason for recall

Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

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