Howmedica Osteonics Corp.: Medical Device Recall in 2023 - (Recall #: Z-1385-2023)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2023.

Data Source: FDA.

Product Description:

stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure

Product Classification:

Class II

Date Initiated: March 10, 2023

Date Posted: April 19, 2023

Recall Number: Z-1385-2023

Event ID: 91913

Reason for Recall:

Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking

Status: Ongoing

Product Quantity: 52 units

Code Information:

GTIN 00848486003746, Lot Number 26270421

Distribution Pattern:

U.S., Netherlands, Japan, China, India, Korea, and Australia.

Voluntary or Mandated:

Voluntary: Firm initiated