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NCAR Recall
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Reference Number:
mdprc 006 04 13 000
Date submitted:
4/2/2013
Manufacturer:
Stryker Osteosynthesis Intramedullary Solutions
Device Type:
Non-sterile fluted surgical drill, AxSOS Calibrated Drill Bit ø4.3mmx263mm
Description:
Non-sterile fluted surgical drill, reusable
Medical Device Identifier:
Manufacturer Part Number: 703615 Lot Numbers: K121854, K225487, K669162
Reason of Field Safety Corrective Action:
Stryker received a report indicating that the scale of the AxSOS Calibrated Drill Bit ø4.3mmx263mm, flat, is incorrect. The scale is used to indicate the correct screw length after the drilling step during surgery, which allows the screw length to be read on the scale and at the end of the drill guide. The incorrect scale could result in the surgeon selecting a screw that is 10mm longer than intended.
Remedy Action:
Please inform users of this Medical Device Removal and pass this notice to all those individuals who need to be aware within your organization. Return all affected products available at your location to Stryker Osteosynthesis.
Athorized Representative/Importer/Distributor:
Al-Faisaliah Medical System, Riyadh, (01) 2119948
Report Source:
NCAR
Source Ref. Number:
CH-2013-03-27-027
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Stryker Osteosynthesis Intramedullary Solutions.pdf
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