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Type of Product	Medical Device
TGA Recall Reference	RC-2014-RN-01131-1
Product Name/Description	AVS PL SPACER (Used as an aid in spinal fixation) AVS PL SPACER 7 X 20 X 4° 9MM Catalogue Number: 48340074 Lot Numbers: 30646, 33494, 39184 AVS PL SPACER 8 X 20 X 4° 9MM Catalogue Number: 48340084 Lot Numbers: 33549, 38164, 38652, 39007, 39160 AVS PL SPACER 7 X 25 X 4° 8MM Catalogue Number: 48345074 Lot Number: 39188 AVS PL SPACER 8 X 25 X 4° 8MM Catalogue Number: 48345084 Lot Numbers: 39150, 38183 ARTG Number: 178870
Recall Action Level	Hospital
Recall Action Classification	Class III
Recall Action Commencement Date	23/10/2014
Responsible Entity	Stryker Australia Pty Ltd
Reason/Issue	The above catalogue numbers are specific to the US and supplied with the US labelling which has a different indication then those devices supplied outside of the US. Specifically, the US versions indicated use with autogenous bone graft in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1. The Australian indication does not include the limit to the contiguous levels or spinal region (L2-S1).
Recall Action	Recall
Recall Action Instructions	Stryker is requesting their customer to identify and return any affected stock. This action has been closed-out on 01/03/2016. This action has been closed-out on 01/03/2016.
Contact Information	1800 803 601 - Stryker Australia