Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Device
Medsafe Reference:24113
Brand Name:OB_OB_LEG
Model:21Y14, 21Y15
Affected:
Software version:
Recalling Organisation:New Zealand Artificial Limb Service
Level 4, 32 Kent Terrace
Wellington 6011
Contact Information:
Manufacturer:Otto Bock Healthcare GmbH
Issue:The manufacturer has identified that for valves that have been delivered during the specified period, the white valve-insert may fall out. The cause of the fault is that some of the installed valve-inserts have a diameter outside the tolerance range. As a result, the intended interference fit assembly may not perform as intended.
Recall action type:Recall
Recall action:Product to be exchanged
Level of recall:Public Recall
Date Commenced:28/1/2019
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