FDA Device recall Z-1220-2017
1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
- FDA Device
- Class II
- terminated
- Published 2017-02-22
On 2017-02-22 the FDA classified a Class II recall of 1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw by Zimmer Biomet, citing the identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1220-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-01-10 |
| Published | 2017-02-22 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Zimmer Biomet |
| Distribution | VA |
Product
1.5mm System, Cranio-maxillofacial Bone Screws 1.5 x 4mm HT SD X-DR Screw, Bone Screw
Reason
The identification of the devices was non-conforming with off-centered slots and the no-go gage starting in the pilot hole.
Identifiers
| code_info | 95-6104- Item No. 530430- Lot 1.5x4mm HT SD X-DR Screw |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1220-2017%22
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