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U.S. Department of Health and Human Services

Class 2 Device Recall A.L.P.S., Distal Tibia Plating System

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 Class 2 Device Recall A.L.P.S., Distal Tibia Plating Systemsee related information
Date Initiated by FirmJune 17, 2015
Date PostedJuly 14, 2015
Recall Status1 Terminated 3 on March 22, 2016
Recall NumberZ-2072-2015
Recall Event ID 71549
Product Classification Forceps, wire holding - Product Code HYA
ProductA.L.P.S. - Medium Bone Plate Forceps. Orthopedic manual surgical instrument.
Code Information Part Number: 816301006 Lot Numbers: 099216, 093776, 093717, 093716, 088526, 081179, 072525, 072524
Recalling Firm/
Manufacturer		 Biomet, Inc.
56 E Bell Dr
Warsaw IN 46582-6989
For Additional Information Contact
574-372-1570
Manufacturer Reason
for Recall		Medium Bone Plate Forceps was assembled with the incorrect grip arm tip. Potential that the surgeon will be unable to provisionally clamp the plate to the patient's bone.
FDA Determined
Cause 2		Vendor change control
ActionOn 6/17/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for locating and returning 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 Commerce223
DistributionDomestic: TX NJ, NC, KY, MA, SD, MO, AL, IN, GA, AR International: Netherlands, Japan, Costa Rica
Total Product Life CycleTPLC 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.
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