Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2016-RN-00678-1
Product Name/Description	Self Tapping Bone Screws, 6.5 x 20 and 6.5 x 25 Self Tapping Bone Screw 6.5 x 20 Part Number: 00-6250-065-20 Lot Number: 63301504 Self Tapping Bone Screw, 6.5 x 25 Part Number: 00-6624-065-25 Lot Number: 63276975 ARTG Number: 169898
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	25/05/2016
Responsible Entity	Zimmer Pty Ltd
Reason/Issue	Zimmer Inc. has become aware of specific lots of sterile Hip and Trauma Implant Screws manufactured between February 2016 and March 2016. These screws are packaged with a double barrier system, two plastic trays and two Tyvek lids, to provide sterile integrity. Process monitoring conducted as part of the standard packaging process identified that in some instances, a small hole may be present in the inner tray, which were found to be caused by a single tool used by the tray supplier in the manufacturing process and estimated to be present in less than 10% of the affected devices. The outer tray is not affected and the device’s sterile integrity remains until the outer tray is opened.
Recall Action	Hazard Alert
Recall Action Instructions	Zimmer is advising surgeons to review the notification and ensure affected personnel are aware of the contents. Patient follow up is at the discretion of the treating surgeon. This action has been closed-out on 27/01/2017.
Contact Information	02 9483 5426 - Zimmer Biomet