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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

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