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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-00596-1
Product Name/Description	Dynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm and 5.0mm, length 32-90 mm, Cobalt Chrome (CoCrMo) sterile Dynamic Locking Screw Stardrive 3.7mm self tapping, length 22-70mm Cobalt-Chrome Alloy (CoCrMo) sterile, Part numbers: 09.213.22S, 09.213.070S Dynamic Locking Screw Stardrive 5.0mm, self-tapping, length 32-90 mm, Cobalt Chrome (CoCrMo) sterile Part number: 09.223.032S, 09.223.090S All lot numbers are affected
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	18/06/2013
Responsible Entity	Synthes Australia Pty Ltd
Reason/Issue	The manufacturer is recalling DLS 3.7mm and 5.0mm following customer complaints of breakages at the distal tip of the pin after successful healing and during planned implant removal of the whole construct. No complaints have been reported by Australian customers.
Recall Action	Hazard Alert
Recall Action Instructions	Customers are requested to quarantine all lots of the 3.7 mm and 5.0 mm Dynamic Locking Screws and contact a Depuy Synthes Trauma sales representative to organise the return of the affected devices. Depuy Synthes is also advising implanting surgeons of the appropriate follow up for patients implanted with the potentially affected Dynamic Locking Screw. For further details, please see http://www.tga.gov.au/safety/alerts-device-dynamic-130704.htm
Contact Information	1800 796 843 - Synthes Australia