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NCAR Recall
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Reference Number:
mdprc 107 06 12 000
Date submitted:
6/19/2012
Manufacturer:
Zimmer inc
Device Type:
Fixed Rod Holder Instruments, PathFinder NXT
Description:
HOLDER, PathFinder NXT Spinal Pedicle Screw System
Medical Device Identifier:
PathFinder NXT Fixed Rod Holder Instruments Part numbers 3573-1 (angle handle) and 3573-2 (straight handle); All lots
Reason of Field Safety Corrective Action:
The tip of the rod holder may crack or break when the rod is manipulated during surgery.
Remedy Action:
This notification is to inform Zimmer Spine Distributors and Sales Agents of the actions to take to notify surgeon customers of the issue and that a redesigned instrument with an improved tip is currently under development and will be provided, when available, to replace part numbers 3573-1 and 3573-2 (for more details see attached)
Athorized Representative/Importer/Distributor:
Ebrahim M. Al-Mana & Bros. Co. Ltd., Riyadh, (01) 4610733
Report Source:
NCAR
Source Ref. Number:
UK-2012-06-13-112
SFDA Comments:
SFDA urges all hospitals that have devices subjected to recall, to contact the company.
Attachments:
Zimmer inc.pdf
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