FDA Device recall Z-1093-2016
Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) Biomet Comprehensive Reverse Shoulder products are indica…
- FDA Device
- Class II
- terminated
- Published 2016-03-16
On 2016-03-16 the FDA classified a Class II recall of Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) Biomet Comprehensive Reverse Shoulder products are indica… by Biomet, citing zimmer Biomet Inc. Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) supplied by Kirkstall Precision was made according to the W1.4034 (420 stainle….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1093-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-02-16 |
| Published | 2016-03-16 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Biomet |
| Distribution | AL, AR, AZ, CA, FL, GA, IL, IN, KS, KY, LA, MA, MD, MI, MO, MS, NC, ND, NE, NJ, NM, NY, OH, OR, PA, PR, SC, TX, UT, VA, WA, WV |
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.
Identifiers
| code_info | all lots of PN: 402852 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1093-2016%22
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