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Type of Product Medical Device
TGA Recall Reference RC-2016-RN-00091-1
Product Name/Description PyroTitan Humeral Resurfacing Arthroplasty Shapers

Multiple Catalogue and Lot Numbers affected

ARTG Number: 111050
Recall Action Level Hospital
Recall Action Classification Class II
Recall Action Commencement Date 28/01/2016
Responsible Entity LMT Surgical Pty Ltd
Reason/Issue It has been determined that certain affected lots of non-conforming product may not be as sharp as intended by design.

This may be evident during use by having to increase the applied force to the shaper needed to cut and form the humeral head effectively for the placement of the implant. This increase in force can in-turn, which could create undesirable friction between the shaper and the humeral head that could potentially result in bone tissue being burned.
Recall Action Recall
Recall Action Instructions Integra LifeSciences is advising users that affected stock can be used if there are no alternatives available. Affected stock will be replaced with unaffected units.
Contact Information 07 3367 6600 - Integra LifeSciences