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Type of Product
Medical Device
TGA Recall Reference
RC-2013-RN-00288-1
Product Name/Description
Locking screw 3.5mm, self tapping, length 55mm, stainless steel, sterile (Orthopaedic bone screw, non-biodegradable)
Part number: 213.055S
Lot numbers: 1875643, 1883109, 1919506, 1937761, 1943552
ARTG number: 157068
Recall Action Level
Hospital
Recall Action Classification
Class II
Recall Action Commencement Date
4/04/2013
Responsible Entity
Synthes Australia Pty Ltd
Reason/Issue
Synthes received two complaints regarding incorrect label/package where the 213.055S, 55mm length locking screw was packaged with a label showing 50mm length.
Recall Action
Recall
Recall Action Instructions
Synthes is requesting that customers quarantine and return units from the affected lots.
Contact Information
1800synthes (1800 7968 437) - Synthes Customer Service