MEDLINE UNITE FOOT & ANKLE DRILL BIT — Class II medical device recall Z-1047-2023
Ongoing recall by MEDLINE INDUSTRIES, LP - Northfield, reported 2023-02-08, distributed nationwide. The recall is due to observed intra-operative screw failure. When pre-drilled with ¿1.3mm drill bit for ¿2.0mm
| Recall number | Z-1047-2023 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | MEDLINE INDUSTRIES, LP - Northfield, Northfield, IL, United States |
| Recall initiated | 2022-12-22 |
| Classified | 2023-02-01 |
| Reported by FDA | 2023-02-08 |
| Distributed | Nationwide (US) |
| Quantity | 190 units |
| UPC / GTIN / UDI-DI | 10888277699113 |
| Model numbers | MPN10013 |
Product
MEDLINE UNITE FOOT & ANKLE DRILL BIT, 1.3MM Solid Core, REF MPN10013
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1047-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.