Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:24545
Brand Name:Xenform Soft Tissue Repair Matrix
Model:
Affected:All batches
Software version:
Recalling Organisation:Boston Scientific NZ Ltd
3 Diamond Street
Eden Terrace
Auckland 1021
Contact Information:0800 742 678
Manufacturer:TEI Bioscences Inc
Issue:Based on a recent FDA decision and the global regulatory environment regarding transvaginal mesh for this indication, the manufacturer has now made the decision to withdraw from inventory, all products from the rest of the world, which are indicated for the transvaginal repair of pelvic organ prolapse.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:10/5/2019
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