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.
This recall has been terminated (originally issued July 5, 2017).
- Recall Initiated
- July 5, 2017
- Terminated
- January 13, 2023
- Recall Number
- Z-0291-2018
- Quantity
- 416 units
- Official Source
- View on FDA website ↗
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.
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 99-93793; Lot (Exp Date) V1409944 (03/09/2020); UDI: 18054242513650. Galaxy UNYCO Diaphyseal Tibia Box: Product Code 99-93794; Lot (Exp Date) V1410194 (04/18/2020). UDI: 18054242513667.
Root Cause
Process change control
Action Taken
Consignees were sent an Urgent Medical Device Recall Notification, dated June 28, 2017, informing them of the device correction. The letter instructed distributors to immediately identify affected product in warehouses, quarantine affected product, and communicate the amount on hand to Orthofix SRL for replacement. Any customers are to be forwarded the recall notice provided to the distributor. Distributors are asked to complete the Reply Form with the appropriate information and to return it to Orthofix by fax at +39-045-6719380 or by e-mail to customerservice@orthofix.it. Hospitals were instructed to identify affected product on-site, quarantine affected units, and communicate the quantity of affected product on-hand to their local distributor or to Orthofix. Affected product will be replaced by Orthofix.