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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-01520-1
Product Name/Description	SynReam Flexible Shaft (re-usable surgical instrument supplied as part of the SynReam medullary reaming system) Part Number: 352.040 Lot Number: 9946822 The SynReam Flexible Shaft may be contained within the following two kits LS SynReam Kit Number: ZXAUTR1671 Equipment Number: 3000072587 SynReam Kit Number: ZXAUTR2316 Equipment Number: 3000108391 ARTG Number: 153666
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	21/11/2016
Responsible Entity	Johnson & Johnson Medical Pty Ltd t/a DePuy Synthes
Reason/Issue	There is the potential that the affected lot of the SynReam Flexible Shaft may have been manufactured with a non-symmetric hexagonal coupling which may result in the reamer shaft not fitting into the reamer heads. In the event that the Flexible Shaft cannot be assembled with the Reamer Head, surgical delay may occur if another device is not available in the surgical suite.
Recall Action	Recall
Recall Action Instructions	JJM is advising customers to immediately quarantine affected product, and then contact JJM who will arrange for return of the product and replacement. This action has been closed-out on 11/05/2017.
Contact Information	1300 562 711 - JJM Customer Service