Recall Z-1220-2017 ยท HWC Screw, Fixation, Bone
Zimmer Biomet, Inc.
1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
| Date | Jan 10, 2017 |
| Status | Terminated |
| Reason | The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole. |
| Root cause | Under Investigation by firm |
| Action | Zimmer Biomet initiated a voluntary recall of 1.5mm System due to identification of non-conformance with off-centered slots and the no-go gage starting in the pilot hole. One distributor with affected product outside of Zimmer Biomet control was notified via email and asked to return the affected product. This communication was sent on via e-mail on January 10, 2017. All product has been returned.There were 89 units in Zimmer Biomet control at the time the removal was initiated, however all 100 are now in Zimmer Biomet control. Customer Service Zimmer Biomet, Inc. P.O. Box 708 Warsaw, IN 4658 |
| Quantity | 11 |
| Distribution | Domestic: None VA/DOD: None Foreign: Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121589 | BIOMET MICROFIXATION FACIAL PLATING SYSTEM Biomet Microfixation, Sep 21, 2012 |