Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2015-RN-01162-1
Product Name/Description	A.L.P.S. 4.0mm Cancellous Locking Screws (non-sterile) CNCLS LOCK SCREW FT 4.0x10mm, 4.0x12mm, 4.0x14mm, 4.0x16mm, 4.0x18mm, 4.0x20mm, 4.0x22mm ,4.0x24mm, 4.0x26mm, 4.0x28mm, 4.0x30mm, 4.0x32mm, 4.0x34mm, 4.0x36mm, 4.0x38mm, 4.0x40mm, 4.0x42mm, 4.0x44mm, 4.0x46mm, 4.0x48mm, 4.0x50mm, 4.0x55mm, 4.0x60mm, 4.0x65mm, 4.0x70mm, 4.0x75mm, 4.0x80mm, 4.0x85mm, 4.0x90mm, 4.0x95mm, 4.0x100mm Multiple Part Numbers Affected All Lot Numbers Affected ARTG Number: 209305
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	30/11/2015
Responsible Entity	Biomet Australia Pty Ltd
Reason/Issue	It has been identified that all lots of A.L.P.S. 4.0mm Cancellous Locking Screws, manufactured between June 1, 2008 and June 4, 2015, have a single lead thread instead of a triple lead thread. A single lead screw may sit proud in the plate which could lead to soft tissue irritation. In addition, if the screw does not lock into the plate, it is possible for the screw to back out. In the event that the screw does not lock into the plate and backs out, a revision surgery may be necessary.
Recall Action	Hazard Alert
Recall Action Instructions	Zimmer Biomet is advising users to inspect stock and quarantine the affected unused units prior to their return to the sponsor. The sponsor will replace the affected unused units. Patients who have been implanted with the affected units should be monitored by qualified healthcare professional. For more details, please see https://www.tga.gov.au/alert/anatomic-locked-plating-system-4-mm-cancellous-locking-screws-used-treat-broken-bones . This action has been closed-out on 29/08/2016.
Contact Information	02 9483 5400 - Zimmer Biomet