Z-1093-2016 Class II Terminated
FDA device recall Z-1093-2016 was initiated by Biomet, Inc. on Feb 16, 2016 and is designated Class II. 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… The recall status is terminated (terminated May 30, 2017). Affected quantity: 1261 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 16, 2016
- Initiation Date
- Feb 16, 2016
- Termination Date
- May 30, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1261 units
Product Description
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.
Distribution Pattern
Worldwide Distribution - US including CA, NY, VA, IL, IN, SC, NC, AR, MO, ND, AL, PA, MI, WA, OR, LA, FL, GA, OH, KS, KY, TX, MA, AZ, NJ, UT, IO, NM, WV, MS, NE, and MD OUS: Australia, Chile, Columbia, Costa Rica, Argentina, Korea, Japan, Panama, Malaysia, Puerto Rico, Canada, and The Netherlands.
Code Information
all lots of PN: 402852
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1093-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026