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Class 2 Device Recall PTHYBRID |
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Date Initiated by Firm |
December 06, 0012 |
Date Posted |
January 09, 2013 |
Recall Status1 |
Terminated 3 on November 08, 2013 |
Recall Number |
Z-0660-2013 |
Recall Event ID |
63850 |
510(K)Number |
K060694
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Product Classification |
Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
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Product |
PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R
Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented |
Code Information |
Part 113950 Lot 093540, 093550,093570,093580,093590,093600,093610,093620,093720, 093730,093740,093760,093770,093780,282590,282600,282620,282630, 282680,282700,282710,489160,489180,489200,489210,489770,489780, 489790,714480,714550,714570,714700,714730,722210,722250,722280, 984770,984780,984790,984800,984810,984820,984830,984840, and 984850 |
Recalling Firm/ Manufacturer |
Biomet, Inc. 56 E Bell Dr Warsaw IN 46582-6989
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For Additional Information Contact |
Audrey Daenzer 574-267-6639 Ext. 1676
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Manufacturer Reason for Recall |
Biomet is recalling Part Number PT-113950 PT Hybrid Glenoid Post, following an investigation which identified that the male thread of the post may be oversized. This oversized condition can vary in degree and may lead to the following three events:
1) If the PT Hybrid Glenoid Post is not fully seated into the Hybrid Base and the implant construct is
implanted, then a gap of 1-3 mm will be prese
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FDA Determined Cause 2 |
Nonconforming Material/Component |
Action |
Biomet Inc. sent a Urgent Medical Device Recall Notices dated December 6, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
The notice identified the reason for the recall including directions to immediately locate, discontinue use of the device. Surgeons were asked to continue monitoring of patients implanted. Customers were asked to confirm receipt of the notice by calling 1-888-348-9500 extension 1570. Customers with product to be returned are asked to obtain RGA # by calling 574-372-6677 . A FAX Back Response Form is to be filled out and sent within 3 days of receipt to 574-372-1683. Biomet, Attention Return Goods, Building B Recalls, 56 East Bell Drive, Warsaw, IN 46580. Questions related to the notice should be directed to 574-371-1570, Monday- Friday 8 a.m. to 5 p.m. |
Quantity in Commerce |
1050 |
Distribution |
Worldwide Distribution -- US (nationwide) including the countries of , Canada, Japan, Argentina, Australia ,Netherlands, Europe and Chile. |
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 = KWS and Original Applicant = BIOMET MANUFACTURING CORP.
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