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U.S. Department of Health and Human Services

Class 2 Device Recall ExploR 7x26mm Modular Radial Stem

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 Class 2 Recall
ExploR 7x26mm Modular Radial Stem
see related information
Date Posted May 13, 2014
Recall Status1 Open
Recall Number Z-1615-2014
Recall Event ID 68144
Premarket Notification
510(K) Numbers
K040611  K051385 
Product Classification Prosthesis, Elbow, Hemi-, Radial, Polymer - Product Code KWI
Product ExploR 7x26mm Modular Radial Stem, Catalog number 11-210062. Elbow prosthesis orthopedic implant.
Code Information Catalog Number: 11-210062 Lot Number Identification: 972230
Recalling Firm/
Manufacturer
Biomet, Inc.
56 E Bell Dr
Warsaw, Indiana 46582-6989
For Additional Information Contact Craig Buchman
574-267-6639 Ext. 1676
Manufacturer Reason
for Recall
This lot of the ExploR Modular Radial Stem may be missing the wedge ramp threads. If the wedge ramp threads are missing from the stem, the likelihood of the set screw loosening from the radial stem intraoperatively is increased. If the set screw loosens, a revision surgery may be necessary.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Biomet sent an URGENT MEDICAL DEVICE SAFETY ALERT dated April 22, 2014 to affected customers. The letter identified the affected product, problem and actions to be taken. 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 8 devices
Distribution US Nationwide Distribution in the states of NY, MD, NC, SC, MI, OR, and NV.
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 = KWI and Original Applicant = BIOMET, INC.
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