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U.S. Department of Health and Human Services

Class 2 Device Recall A.L.P.S.

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  Class 2 Device Recall A.L.P.S. see related information
Date Initiated by Firm June 04, 2015
Date Posted July 10, 2015
Recall Status1 Terminated 3 on March 22, 2016
Recall Number Z-2058-2015
Recall Event ID 71423
510(K)Number K111663  
Product Classification bone fixation screw - Product Code HRS
Product A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
Code Information Part number:856135060 Lot: 061300
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact Audrey Daenzer
574-372-1570
Manufacturer Reason
for Recall		 Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection.
FDA Determined
Cause 2		 Packaging
Action On 6/4/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for removing the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. 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 50 units
Distribution Domestic: None. International: Netherlands and Japan
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 = HRS and Original Applicant = DEPUY ORTHOPAEDICS, INC.
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