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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