Orthofix Power Drill Torque Limiter — Class II medical device recall Z-0291-2018
Terminated recall by Orthofix Srl, reported 2018-01-03, distributed in CA, FL, PA. The power drill torque limiter may break during use in surgery application.
| Recall number | Z-0291-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthofix Srl, Bussolengo, N/A, Italy |
| Recall initiated | 2017-07-05 |
| Classified | 2017-12-27 |
| Reported by FDA | 2018-01-03 |
| Terminated | 2023-01-13 |
| Distributed | CA, FL, PA |
| Countries outside the US | AU, CH, DE, FI, FR, GB, IT, LT, NL, SE, SG, ZA |
| Quantity | 416 units |
| Reason classes | device malfunction |
| UPC / GTIN / UDI-DI | 01805424515159, 18054242512318, 18054242512325, 18054242513629, 18054242513643, 18054242513650, 18054242513667, 18054242515166 |
| Lot numbers | B1012462, B1012776, B1019281, B1019282, B1019431, B1031608, B1049195, B1052165, B1080028, B1083360, B1099157, B1107271, R1412578, V1388296, V1388432, V1389818, V1389819, V1389857, V1389886, V1399881, V1400707, V1400800, V1400940, V1402023, V1405602, V140597, V1406422, V1408711, V1409944, V1410026, V1410027, V1410082, V1410194, V1414451, V1421785, V1422854, V1425406, V1427350, V1429217 |
Product
Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal Tibia Sterile Kit, Galaxy UNYCO Mini Kit Instruments Sterile, Galaxy UNYCO Diaphyseal Femur Box, Galaxy UNYCO Knee Bridging Box, Galaxy UNYCO Ankle Bridging Box - Unilateral Frame, Galaxy UNYCO Ankle Bridging Box - Delta Frame, and Galaxy UNYCO Diaphyseal Tibia Box. Intended to be used for temporary bone stabilization in trauma and orthopedic procedures of the lower limb prior to definitive treatment.
Reason for recall
The power drill torque limiter may break during use in surgery application.
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-0291-2018. 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.