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U.S. Department of Health and Human Services

Class 2 Device Recall Power Drill Torque Limiter

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  Class 2 Device Recall Power Drill Torque Limiter see related information
Date Initiated by Firm July 05, 2017
Create Date December 27, 2017
Recall Status1 Open3, Classified
Recall Number Z-0291-2018
Recall Event ID 77789
510(K)Number K142052  K153233  
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
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.
Code Information 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.
Recalling Firm/
Manufacturer
Orthofix Srl
Via Delle Nazioni 9
Bussolengo Italy
Manufacturer Reason
for Recall
The power drill torque limiter may break during use in surgery application.
FDA Determined
Cause 2
Process change control
Action 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.
Quantity in Commerce 416 units
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.
Total Product Life Cycle TPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KTT and Original Applicant = ORTHOFIX SRL
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