Recall Z-2058-2015 ยท HRS Plate, Fixation, Bone
Biomet, Inc.
A.L.P.S., 3.5mm x 60 mm Cortical Locking Screw. Bone fixation screw
| Date | Jul 10, 2015 (initiated Jun 4, 2015) |
| Status | Terminated |
| Reason | Sterile packaging was not sealed. The implantation of an unsterile screw may lead to infection. |
| Root cause | Packaging |
| Action | On 6/4/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors with instructions for removing the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday 8 a.m.to 5 p.m. |
| Quantity | 50 units |
| Distribution | Domestic: None. International: Netherlands and Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K111663 | TRAUMA INTERNAL FIXATION SYSTEMS DePuy Orthopaedics, Inc., Mar 12, 2012 |