Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2017-RN-00233-1
Product Name/Description	Biolox Forte 36mm Alumina Ceramic Head Ceramic Femoral Head 36mm SLT Taper Short Neck Part Number: 26000010 Ceramic Femoral Head 36mm SLT Taper Medium Neck Part Number: 26000011 Ceramic Femoral Head 36mm SLT Taper Long Neck Part Number: 26000012
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	17/02/2017
Responsible Entity	Surgical Specialties Pty Ltd
Reason/Issue	An investigation was completed following a complaint by a surgeon that the ceramic femoral head was shorter by 2mm than other 36mm MicroPort femoral heads. MicroPort's investigation confirmed this complaint and concluded that the MicroPort 36mm ceramic femoral heads have been manufactured to this specification for over 15 years. The main complaint issue associated with this finding would be surgical revision for dislocation or laxity of the hip joint.
Recall Action	Hazard Alert
Recall Action Instructions	Surgical Specialties is advising surgeons to maintain their usual follow-up protocol and actions for their patients and to ensure that these patients are informed about symptoms (particularly pain, instability, difficulty walking and/or performing common tasks) that indicate the need for revision surgery. This action has been closed-out on 22/03/2018.
Contact Information	1300 665 884 - Surgical Specialties