Print version of this report
Type of Product Medical Device
TGA Recall Reference RC-2016-RN-01053-1
Product Name/Description Allen Wrench 5mm in SMR supplied in instrument set (surgical instrument used during implantation of SMR anatomic and Reverse shoulder prosthesis)

Allen Wrench 5mm
Product Code: 9013.50.210
Lot Number: 14AA311

SMR instrument set
Product Codes: 9013.23.000, 9013.43.000, 9013.45.000

ARTG Number: 176592
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 10/08/2016
Responsible Entity Lima Orthopaedics Australia Pty Ltd
Reason/Issue The manufacturer, LimaCorporate has received two complaints about the Allen Wrench. Firstly, the impossibility to connect the Allen Wrench to the T-handle intra-operatively. Secondly, after a difficult insertion, it was impossible to remove the Allen Wrench from the T-handle. In both cases, there were no reported consequences for the patients.

LimaCorporate's investigations have shown that the diameter of the Zimmer connection on the Allen Wrench has been manufactured out of specification and is over-dimensioned. This leads to difficult/impossible coupling between the Allen Wrench and the T-handles.
Recall Action Recall
Recall Action Instructions Lima Orthopaedics' kit coordinator will be visiting hospitals and replacing affected devices in the SMR instrument sets with unaffected devices. This action has been closed-out on 20/02/2017.
Contact Information 03 9550 0221 - Lima Orthopaedics