Class 2 Device Recall Verso Shoulder Forked Retractor

• Date Initiated by Firm: February 16, 2016
• Date Posted: March 10, 2016
• Recall Status: Terminated on May 30, 2017
• Recall Number: Z-1093-2016
• Recall Event ID: 73173
• Product Classification: Retractor - Product Code GAD
• 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.
• Code Information: all lots of PN: 402852
• Recalling Firm/ Manufacturer: Biomet, Inc.; 56 E Bell Dr; Warsaw IN 46582-6989
• For Additional Information Contact: Amanda Zajicek; 574-372-6782
• Manufacturer 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.
• FDA Determined Cause: Mixed-up of materials/components
• Action: Zimmer Biomet sent an Urgent Medical Device Recall letter dated February 16, 2016, to all affected consignees. The letter identified the product, the problem, and the action to be taken by the customer. The following actions are REQUIRED: Immediately locate and remove the identified device(s) listed below from circulation. Carefully follow the instructions on the enclosed Response Form . Email a copy of the response form to CPWARFieldAction@zimmerbiomet.com prior to return of product. Use priority carrier for your shipment. If you have further distributed this product, you MUST notify hospital personnel of this action via the enclosed Dear Risk/Recall Manager notice. This letter MUST be given to hospital personnel responsible for receiving recall notices. However, you are charged with the location and return of these products. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA: Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
• Quantity in Commerce: 1261 units
• Distribution: 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.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.