Recall Z-1093-2016— Biomet, Inc.

Class II FDA medical device recall by Biomet, Inc., initiated 2016-02-16, terminated 2017-05-30. FDA's recall record names no specific 510(k) clearance for this event. Product: Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) 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. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.. Reason: Zimmer Biomet Inc. Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) supplied by Kirkstall Precision was made according to the W1.4034 (420 stainless) which does not conform to 420 S29 indicated on the print. All units manufactured to date were manufactured using 420 stainless. Therefore, all lots of PN: 402852 are considered in scope..

Recalling firm

Biomet, Inc.

Classification

Class II

Status

Terminated

Initiated

2016-02-16

Terminated

2017-05-30

Firm location

Warsaw, IN, United States

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