Print version of this report

Type of Product	Medical Device
TGA Recall Reference	RC-2012-RN-00938-1
Product Name/Description	SPIRALOK Anchors (suture anchors used to reattach soft tissue to bone in orthopaedic surgery) Product Codes: 222960, 222961, 222962, 222963, 222985, 222986, 222987 & 222988 ARTG Numbers: 136226, 136227, 136226, 136227, 123272, 123017, 123272 & 123017
Recall Action Level	Hospital
Recall Action Classification	Class II
Recall Action Commencement Date	14/09/2012
Responsible Entity	Johnson & Johnson Medical Pty Ltd T/A Depuy Australia
Reason/Issue	Testing has indicated that the Spiralok Anchors may not be as robust compared to other similarly indicated anchors and is removing it from the market.
Recall Action	Recall
Recall Action Instructions	Customers are requested to quarantine affected stock and contact the sponsor to organise return. Physicians are advised to report any patient events involving fractured anchors to the sponsor.
Contact Information	1300 562 711 - Johnson & Johnson Medical Customer Service