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Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00928-1
Product Name/Description	Avenir Müller Stem 6 Lateral uncemented and Avenir Müller Stem 4 Standard uncemented (used as the component in total hip arthoplasty) Avenir Müller Stem 6 Lateral uncemented Reference Number: 01.06010.106 Lot Number: 4023094 Avenir Müller Stem 4 Standard uncemented Reference Number: 01.06010.004 Lot Number: 4022860 ARTG Number: 216175
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	12/07/2016
Responsible Entity	Zimmer Pty Ltd
Reason/Issue	The Avenir Müller Stem 6 lateral uncemented may have been placed in the packaging of the Avenir Müller Stem 4 standard uncemented and vice versa. The surgeon may have used a standard stem instead of a lateral stem. For the standard stem the offset is 6mm smaller and therefore an increased laxity of the hip might result. This could conduct to a risk of luxation, pain or revision surgery.
Recall Action	Hazard Alert
Recall Action Instructions	Zimmer is advising users that use of a standard stem instead of a lateral stem may result in an increased laxity of the hip, and may result in pain or revision surgery. This action has been closed-out on 17/02/2017.
Contact Information	02 9483 5426 - Zimmer Biomet