Horus Tmc

Recalling firm
Evolutis New Zealand Limited
Product
Horus TMC. [Device]. Model: HORUS TMC cup. Affected: LOT numbers: 2010965, 2016014, 2017024, 2022633, 2021733
Reason
The device size is engraved on the back of the insert. A deviation has been observed in the depth of this engraving, which poses a potential risk of the thickness being less than the approved thickness., The potential consequence is premature wear of the insert. All new batches manufactured since May 2026 comply with the requirements (no size engraving). Affected product that has not been implanted has been destroyed and replaced with new the new batch references so you will not receive any affected batches moving forward.
Classification
Class I
Category
medical device recall
Country
New Zealand
Agency
MEDSAFE
Recall date
2026-06-29
Status
Ongoing
Distribution
New Zealand - Healthcare Professional

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/65013b60-75e3-442a-8efd-d70b5260c3d5