Recall Z-0660-2013 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Biomet, Inc.
PT113950 PT HYBRID Glenoid Post Regenerex porous titanium construct Sterile R Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
| Date | Jan 9, 2013 (initiated Dec 6, 12) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 Re |
| Quantity | 1050 |
| Distribution | Worldwide Distribution -- US (nationwide) including the countries of , Canada, Japan, Argentina, Australia ,Netherlands, Europe and Chile. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060694 | MODULAR HYBRID GLENOID Biomet Manufacturing Corp, Dec 11, 2006 |