Recall Z-2046-2015 ยท HRS Plate, Fixation, Bone
Biomet, Inc.
A.L.P.S. Foot Locking Calcaneus Plate,Small-Right. Provides the orthopaedic surgeon a means of bone fixation and helps generally in the management of fractures and reconstructive surgeries.
| Date | Jul 8, 2015 (initiated Jun 4, 2015) |
| Status | Terminated |
| Reason | The thread location on one of the thread holes is offset from the axis of the predrill hole. The threads are too deep on one side and too shallow on the other. The locking screw may back out of the plate if it does not achieve proper purchase. This may require a revision surgery to replace or remove the screw and/or plate. The threads, not uniformly loaded, may shear off, causing metal slivers. |
| Root cause | Process change control |
| Action | On June 4, 2015 an URGENT MEDICAL DEVICE REMOVAL letter was sent to all consignees. This action requires the immediate location and discontinued use of the product and its return to Biomet. The following actions are REQUIRED: Immediately locate and remove the identified device(s) listed below from circulation; Carefully follow the instructions on the enclosed "Response Form"; Email a copy of the Response Form to audrey.daenzer@biomet.com prior to return of product; Use priority carrier for your shipment; and If you have further distributed this product, you MUST notify hospital personnel of th |
| Quantity | 75 units |
| Distribution | Distributed in the states of TX, MD, PA, NJ, NC, MA, AZ, GA, FL, and AR. and the countries of Costa Rica CP and The Netherlands. |
| FDA record | Open on fda.gov |