Reported Jan 3, 2018 · Terminated
Orthofix Power Drill Torque Limiter, Sterile, Rx Only, Single Use; Sold individually and in the Galaxy UNYCO Diaphyseal…
Orthofix Srl
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Orthofix Srl · Via Delle Nazioni 9 · Bussolengo, N/A · N/A
Is this the product you have?
- 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.
- Lot codes and dates
17 of 17 products
Products covered by this recall Model / number Barcodes Product as published 99-93568— — Lot (Exp Date) V1388296 (12/28/2019), V1388432 (12/29/2019), V1389857 (01/13/2020), V1400707 (05/18/2020), V1400940 (05/23/2020), V1410027 (09/01/2020) 99-9350618054242512318UDI: 18054242512318. Galaxy UNYCO Diaphyseal Tibia Sterile Kit — Lot (Exp Date) V1389818 (01/12/2020), V1389819 (01/12/2020), V1389886 (02/13/2020), V1399881 (05/10/2020), V1400800 (05/22/2020), V1402023 (06/03/2020), V1405602 (07/17/2020), V1406422 (07/26/2020), V1410082 (09/02/2020), R1412578 (09/28/2020), V1414451 (10/19/2020), V1421785 (02/01/2021), V1425406 (03/13/2021), B1012462 (06/19/2021), B1012776 (06/26/2021), B1019431 (07/05/2021), B1031608 (08/05/2021), B1052165 (10/23/2021), B1049195 (10/25/2021), B1080028 (02/16/2022), B1099157 (04/08/2022), B1107271 (04/09/2022) 99-9350918054242512325UDI: 18054242512325. Galaxy UNYCO Mini Kit Instruments Sterile — Lot (Exp Date) V1408711 (08/01/2020), V1410026 (09/01/2020), V1422854 (02/14/2021), V1427350 (04/09/2021), V1429217 (04/26/2021), B1083360 (02/20/2022) 99-9379018054242513629UDI: 18054242513629. Galaxy UNYCO Diaphyseal Femur Box — Lot (Exp Date) B1019281 (04/09/2021) 99-937911805424515159UDI: 1805424515159. Galaxy UNYCO Knee Bridging Box — Lot (Exp Date) B1019282 (04/09/2021) — 18054242515166UDI: 18054242515166. Galaxy UNYCO Ankle Bridging Box - Unilateral Frame 99-93792— — Lot (Exp Date) V140597 (03/21/2020) 99-9379318054242513643UDI: 18054242513643. Galaxy UNYCO Ankle Bridging Box - Delta Frame — Lot (Exp Date) V1409944 (03/09/2020) 99-9379418054242513650UDI: 18054242513650. Galaxy UNYCO Diaphyseal Tibia Box — 18054242513667Lot (Exp Date) V1410194 (04/18/2020). UDI: 18054242513667. - Amount recalled
- 416 units
Where it was sold
Why it was recalled
The power drill torque limiter may break during use in surgery application.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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