Database updated: 27 October 2026

Safety Information

Medsafe Online Recall Database

Detail of Recall

Type of Product:Medicine
Medsafe Reference:16202
Brand Name:DePuy CMW 2 Gentamicin
Dose Form/Strength:bone cement 20 g (powder component)
Affected:3590475, 3607803, 3620321, 3625505
Recalling Organisation:Johnson & Johnson (New Zealand) Limited
507 Mt Wellington Highway
Mt Wellington
AUCKLAND 1060
Contact Information:0800 922 638
Manufacturer:DePuy International Ltd t/a DePuy CMW
Issue:Four batches of incorrectly labelled product distributed in NZ - Incorrect strength of gentamicin specified on outer packaging.
The amount of gentamicin detailed on the unit outer carton label is incorrectly stated as 1.0 M.I.U. (Million International Units). This should be labelled 0.5 M.I.U. Information on the foil pouch and IFU is correct. The composition of the mislabelled bone cement complies with the product specifications and the cement functions according to design intent. The affected lots should be used in the normal manner in accordance with the IFU, and the gentamicin content on the outer carton label for these batches should be disregarded.
Recall action type:Recall
Recall action:Recall
Level of recall:Wholesale
Date Commenced:3/3/2014
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