Recall Z-0136-2016 ยท GWO Plate, Cranioplasty, Preformed, Alterable
Biomet Microfixation, LLC
Neuro Combo Set Case The cases hold surgical instrumentation in place during handling and storage.
| Date | Aug 6, 2015 |
| Status | Terminated |
| Reason | The lids on implant caddies within P/N 17-5000 and 19-5000 could not be opened by the user without application of undesirable/unexpected excessive force. |
| Root cause | Component change control |
| Action | Biomet Microfixation made phone calls on August 6, 2015 and an initial notice letter sent via FedEx on August 6, 2015, to all distributors. During the phone conversation the distributors confirmed that the inventory invoiced to them is currently in their possession and were asked to remove the lids from the trays and return them back to Biomet Microfixation. In conjunction to the Initial Notice, replacement lids were sent to their business address. Followup communication would be distributed until all units are returned to Biomet Microfixation. Distributors were instructed to do the following |
| Quantity | 37 cases |
| Distribution | Nationwide Distribution including CA, FL, OK, NY, NC, and IL. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121624 | BIOMET MICROFIXATION NEURO PLATING SYSTEM Biomet Microfixation, Oct 12, 2012 |