Mako Robotic Surgical Navigation System Application Software

Recalling firm

Stryker New Zealand Ltd

Product

MAKO Robotic surgical navigation system application software. [Device]. Model: TKA 2.1, THA 4.2, PKA 3.1 Install Disk - THA 5.0, TKA 2.1, PKA 3.1 Install Disk - TKA 3.0, THA 5.0, PKA 3.1 Install Disk - TKA 3.0, THA 4.2, PKA 3.1 Install Disk. Affected: Catalogue Numbers - 700002834690, 700003123526

Reason

The manufacturer has become aware that there is the potential for the user to experience a discrepancy in the on-screen visualisation of bone resection and the actual amount of bone removed during the reaming process when using Total Hip Arthroplasty (THA) 4.2 and THA 5.0 applications on the Mako 4 Robotic Arm (P/N 229999)., The user may observe excessive red and/or a black area in the acetabulum displayed on the screen when there is pelvic motion in a certain direction relative to the reamer.

Classification

Class I

Category

medical device recall

Country

New Zealand

Agency

MEDSAFE

Recall date

2026-07-03

Status

Ongoing

Distribution

New Zealand - Hospital/Pharmacy/Laboratory

Official recall notice from MEDSAFE

Recall details on Nibble Recalls: https://trynibble.app/recalls/1c9e558f-0d9b-4311-91c4-72d5757a9218