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U.S. Department of Health and Human Services

Class 2 Device Recall Superior Approach Resection Guide Assembly

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 Class 2 Recall
Superior Approach Resection Guide Assembly
see related information
Date Posted June 17, 2013
Recall Status1 Open
Recall Number Z-1548-2013
Recall Event ID 65212
Premarket Notification
510(K) Number
K080642 
Product Classification Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, Cemented - Product Code PAO
Product Superior Approach Resection Guide Assembly. Indicated for primary, fracture, or revision total shoulder replacement for the relief of pain.
Code Information Catalog number: 010001814 and lot numbers: 318520 and 644720.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582-6989
For Additional Information Contact Audrey Daenzer
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall
Biomet has initiated this action following an investigation which identified that the slot on the resection guide is offset in the wrong direction. When the slot on the resection guide is offset in the wrong direction, the Steinman pin that is intended to hold the guide into place may not come into contact with the bone.
FDA Determined
Cause 2
DESIGN: Device Design
Action On 5/15/2013 an URGENT MEDICAL DEVICE RECALL notification was sent to all consignees detailing to immediately locate and discontinue use of the product and return to Biomet. The following actions are REQUIRED: -Immediately locate and remove the identified device(s) listed below from circulation . -Carefully follow the instructions on the enclosed "FAX Back Response Form" . -Fax a copy of the Response Form to 574-372-1683 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 O.R. Manager" notice. This letter MUST be given to hospital personnel responsible for receiving recall notices.
Quantity in Commerce 17
Distribution Worldwide Distribution-USA (nationwide) including the states of UT, TX, AL, KY, and WI, and the countries of Australia, The Netherlands, Korea, and Canada.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = PAO and Original Applicant = BIOMET, INC.
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