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U.S. Department of Health and Human Services

Class 2 Device Recall Optilock, Locking Screw 3.5mm x 28mm

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 Class 2 Recall
Optilock, Locking Screw 3.5mm x 28mm
see related information
Date Posted April 19, 2012
Recall Status1 Terminated on August 29, 2013
Recall Number Z-1439-2012
Recall Event ID 61188
Premarket Notification
510(K) Number
K062494 
Product Classification Plate, Fixation, Bone - Product Code HRS
Product Optilock, Locking Screw 3.5 mm x 28 mm, non sterile, REF 37728, Biomet Trauma Parsippany, NJ 97054. Cortical Locking Screw for securing a Proximal Humeral Plate to the bone in the Optilock system.
Code Information Item 37728, Lot 989520; Lot 850910 ; Lot 091250 Lot 429270
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582-6989
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
Biomet initiated this action after a complaint was received that item 36728, Non-Locking Screw 3.5mm x 28mm was in a package labeled as 37728, Locking Screw 3.5mm x 28mm.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action A March 15 2012 Urgent Medical Device Recall Notice was sent to Distributors, Operating Room Managers, and Physicians with directions to locate and remove recalled items with instructions to provide the recall notice to any sub-accounts. The letter also identified the affected product and explained the reason for the recall. OR Managers and Physicians are to confirm recall notice receipt by calling 800-348-9500, extention 3983 or 3009 and make arrangements for product return. Distributors are to complete and FAX back the response tracking form to the attention of Angi Dickson, Biomet @ 574-372-1638. Questions should be directed to 574-372-3983 or 574-371-3009 M- F, 8 AM- 5 PM, (ET).
Quantity in Commerce 45
Distribution Worldwide Distribution -- USA, including NJ, TX, VA, MI IL, KT, & Puerto Rico, and country of the Netherlands.
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 = HRS and Original Applicant = EBI, L.P.
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