Data Foundry

Medical device recalls 2016

Verso Shoulder Forked Retractor — Class II medical device recall Z-1093-2016

Terminated recall by Biomet, Inc., reported 2016-03-16, distributed in AL, AR, AZ, CA, FL, GA, IL, IN…. Zimmer Biomet Inc. Verso Shoulder Forked Retractor (Comprehensive Instrumentation 2 Prong Retractor) supplied

Recall numberZ-1093-2016
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmBiomet, Inc., Warsaw, IN, United States
Recall initiated2016-02-16
Classified2016-03-10
Reported by FDA2016-03-16
Terminated2017-05-30
DistributedAL, 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
Countries outside the USAR, AU, CA, CL, CR, JP, KR, MY, NL, PA
Quantity1,261 units
Lot numbers402852

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 for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1093-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.