FDA Device recall Z-1047-2023
MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
- FDA Device
- Class II
- ongoing
- Published 2023-02-08
On 2023-02-08 the FDA classified a Class II recall of MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013 by Medline Industries Northfield, citing the recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failur….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1047-2023 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2022-12-22 |
| Published | 2023-02-08 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Medline Industries Northfield |
| Distribution | US |
Product
MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
Reason
The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm screws and ¿1.6mm drill bit for ¿2.4mm we have observed screw failure due to excessive torque.
Identifiers
| code_info | GTIN 10888277699113, Lot Number ? |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1047-2023%22
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