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U.S. Department of Health and Human Services

Class 2 Device Recall Shoulder humeral tray

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  Class 2 Device Recall Shoulder humeral tray see related information
Date Initiated by Firm April 22, 2011
Date Posted June 09, 2011
Recall Status1 Terminated 3 on February 21, 2013
Recall Number Z-2544-2011
Recall Event ID 58571
510(K)Number K080642  
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
Product Comprehensive reverse shoulder humeral tray with locking ring, 44 mm +5 mm, sterile, single use, REF 115345, Biomet Orthopedics, Warsaw, IN.

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 M016170, M075380, M132040, M153440, M216030, M436800, M482790, M482810, M482820, M482830, M513600, M513610, M513620, M559110, M597720, M620280, M696340, M698060, M717560, M717570, M732600, M788700, M858260, M865130, M906860, M950410, M964940 and  M987720.  
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582
For Additional Information Contact Mary Johnson
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall		 The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.
FDA Determined
Cause 2		 Employee error
Action The firm, Biomet Orthopedics, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 22, 2011 to their customers. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately locate the recalled product; discontinue use; return the product back to Biomet; confirm receipt of the notice by calling 800-348-9500 extension 1368 or 1325, and complete and return the attached form via fax to: 574-372-1683 or mail to: Biomet, 56 East Bell Drive, Warsaw, IN 46580. Customers with questions regarding this recall should call 800-348-9500 extension 1368 or 1325.
Quantity in Commerce 1575 units all products
Distribution Worldwide distribution: USA (nationwide) including: Puerto Rico and countries including: Australia, Canada, Chile, Columbia, Costa Rica, Korea and 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.
510(K) Database 510(K)s with Product Code = KWS and Original Applicant = BIOMET, INC.
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