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Class 2 Device Recall ExploR 7x26mm Modular Radial Stem |
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Date Initiated by Firm |
April 22, 2014 |
Date Posted |
May 13, 2014 |
Recall Status1 |
Terminated 3 on January 13, 2015 |
Recall Number |
Z-1615-2014 |
Recall Event ID |
68144 |
510(K)Number |
K040611 K051385
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Product Classification |
Prosthesis, elbow, hemi-, radial, polymer - Product Code KWI
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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 IN 46582-6989
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For Additional Information Contact |
Craig Buchman 574-267-6639 Ext. 1676
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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.
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FDA Determined Cause 2 |
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
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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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510(K) Database |
510(K)s with Product Code = KWI and Original Applicant = BIOMET, INC.
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