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Type of Product	Medical Device
TGA Recall Reference	RC-2013-RN-01250-1
Product Name/Description	Zimmer Periarticular Femoral Cond Buttress Plate and Zimmer Periarticular Distal Lateral Femoral Locking Plate All Lots with an expiration date prior to July 24, 2023 FEM COND BUTTRESS PLT, RT: 00-2347-001-12, 14, 16, 18 FEM COND BUTTRESS PLT, LT: 00-2347-002-12, 14, 16, 18 DIST LAT FEM LOCK PLT, RT: 47-2357-101-14, 18 DIST LAT FEM LOCK PLT, LT: 47-2357-102-14, 18
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	26/11/2013
Responsible Entity	Zimmer Pty Ltd
Reason/Issue	Zimmer recently conducted a review of historic packaging validations. Based on this review, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration, consisting of an inner and outer sterile tray, resulted in cosmetic failures related to the visual quality of the seal (homogeneous adhesive transfer). This failure occurred on 3 of 154 tray samples tested and was observed on inner trays only. No physical failures in either peel strength or pressure testing were observed.
Recall Action	Recall
Recall Action Instructions	Hospitals are requested to quarantine all affected product in their inventory. Return of affected product can be organised through a Zimmer Sales Representative.
Contact Information	1800 803 263 - Zimmer Customer Service Number