Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:19260
Brand Name:Coloplast Kiwee Testicular Implants
Model:PR3001, PR3002, PR3003, PR3004, PR3005
Affected:All lots
Software version:
Recalling Organisation:Culpan Distributors Ltd
Unit 10
19 Hannigan Drive
Mt Wellington
Auckland
Contact Information:09 570 5752
Manufacturer:Coloplast A/S
Issue:Implants manufactured by Silimed under contract to Coloplast, have had their CE Mark suspended following an inspection of the manufacturing facilities.
Recall action type:Recall
Recall action:Product to be returned to supplier
Level of recall:Hospital/Pharmacy/Laboratory
Date Commenced:16/10/2015
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