Enforcement Report - Week of January 16, 2013
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Event Detail
| Event ID | 63850 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Biomet, Inc. |
| City | Warsaw |
| State | IN |
| Country | US |
| Voluntary/Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-12-06 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution -- US (nationwide) including the countries of , Canada, Japan, Argentina, Australia ,Netherlands, Europe and Chile. |
Product Detail
| Product Description | Code Info | Classification | Reason for Recall | Product Quantity | Recall Number |
|---|---|---|---|---|---|
| PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | 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 | Class II | 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 present. 2) If excessive torque is applied to assemble the post into the base, the PT Hybrid Glenoid Post drive tip could break off. 3) The PT Hybrid Glenoid Post may not thread at all into the Hybrid Glenoid Base, which would prevent assembly of the two implant components. | 1050 | Z-0660-2013 |
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