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U.S. Department of Health and Human Services

Class 2 Device Recall Biomet Reverse Humeral Inserter

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 Class 2 Recall
Biomet Reverse Humeral Inserter
see related information
Date Posted September 30, 2011
Recall Status1 Terminated on October 26, 2011
Recall Number Z-3289-2011
Recall Event ID 59724
Premarket Notification
510(K) Number
K023063 
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product Comprehensive Reverse Humeral Fracture Inserter REF 406993 Comprehensive Instrumentation Reverse Humeral Inserter QTY 1. Instrument that is attached to the trial prosthesis for placement in the prepared bone canal to check for correct sizing, version and humeral length. Also used to insert the humeral implant into the canal.
Code Information Part numbers: 406993, Lot numbers:176070 and 657550; and 406993-00, Lot number : 203119.
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582-6989
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Biomet Customer Service
574-372-1570
Manufacturer Reason
for Recall
Recall initiated in response to a Biomet Canada report, which noted that while testing the instruments, the pin used to secure the implant on the device did not engage on the effected lots and were distributed.
FDA Determined
Cause 2
COMPONENT CONTROLS (GMP - GOOD MANUFACTURING PRACTICE): Nonconforming Material/Component
Action On 8/3/11 Biomet Orthopedics sent an "URGENT MEDICAL DEVICE RECALL NOTICE" letter to all affected customers. The letter included: reason for the recall, risks associated with use of the device, and alternate instructions for use of the recalled device. Customers are instructed to locate the affected products, discontinue use, return the devices, and a fax a copy of the response form. For information or questions on this recall call Biomet at (574) 372-1570.
Quantity in Commerce 6 units (internationally)
Distribution International Distribution Only: Canada, Australia, and Columbia.
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 = LXH and Original Applicant = BIOMET ORTHOPEDICS, INC.
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