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,
Check against the official notice below — it lists the full affected range.
Orthofix Srl is recalling 416 units of its Orthofix Power Drill Torque Limiter, which is a sterile, single-use surgical device sold individually and as part of several Galaxy UNYCO kits. The power drill torque limiter may break during use in surgery. The affected products were distributed worldwide, including to the United States (specifically California, Florida, and Pennsylvania) and to Australia, Germany, Finland, France, Italy, Lithuania, the Netherlands, Singapore, South Africa, Sweden, Switzerland, and the United Kingdom.
The affected products include specific lot numbers with expiration dates ranging from December 2019 through April 2022. The recall includes the Power Drill Torque Limiter (Product Code 99-93568) and several Galaxy UNYCO kits: the Diaphyseal Tibia Sterile Kit, Mini Kit Instruments Sterile, Diaphyseal Femur Box, Knee Bridging Box, and Ankle Bridging Box models. The source does not specify what remedy or action affected consumers should take.
Written by software from the official notice below. Not reviewed by a lawyer.
The power drill torque limiter may break during use in surgery application.
Reason for recall: The power drill torque limiter may break during use in surgery application. Distribution: Worldwide Distribution -- US, including the states of CA, FL, & PA; and, the countries of Australia, Germany, Finland, France, Italy, Lithuania, Netherlands, Singapore, South Africa, Sweden, Switzerland, & United Kingdom. Quantity: 416 units Lot/code info: Power Drill Torque Limiter: Product Code 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); UDI: 18054242512318. Galaxy UNYCO Diaphyseal Tibia Sterile Kit: Product Code 99-93506; 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); UDI: 18054242512325. Galaxy UNYCO Mini Kit Instruments Sterile: Product Code 99-93509; 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); UDI: 18054242513629. Galaxy UNYCO Diaphyseal Femur Box: Product Code 99-93790; Lot (Exp Date) B1019281 (04/09/2021); UDI: 1805424515159. Galaxy UNYCO Knee Bridging Box: Product Code 99-93791; Lot (Exp Date) B1019282 (04/09/2021); UDI: 18054242515166. Galaxy UNYCO Ankle Bridging Box - Unilateral Frame; Product Code 99-93792; Lot (Exp Date) V140597 (03/21/2020); UDI: 18054242513643. Galaxy UNYCO Ankle Bridging Box - Delta Frame: Product Code 99-9
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.