The Recall Desk
HighFDA (Devices)·Z-1386-2023·Announced 2023-04-19

Stryker MAKO RESTORIS tibial baseplate trial recalled for incorrect size marking

Stryker is recalling 102 units of MAKO RESTORIS MultiCompartmental Knee tibial baseplate trials with incorrect size laser markings. Wrong markings could lead to selection of incorrect implant sizes during partial knee replacement surgery.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II marking defect on a surgical device presents risk of harm if incorrect size implants are selected during surgery. No illnesses or injuries have been reported. This fits the rubric criterion for a risk-of-harm product where injury has not yet occurred.

Plain-English summary

Stryker, through its subsidiary Howmedica Osteonics Corp., is recalling lot 26250421 of the MAKO RESTORIS MultiCompartmental Knee (MCK) tibial baseplate trial (reference 170616, size 6 RM/LL). These trial implants are intended for use during partial knee arthroplasty surgical procedures.

The recalled units have incorrect size laser markings on the baseplate. Using implants with incorrect size markings could result in selection of the wrong implant size during surgery.

A total of 102 units were distributed in the United States, Netherlands, Japan, China, India, Korea, and Australia. Persons or facilities that have received this product should discontinue use and contact Howmedica Osteonics Corp. for replacement or return instructions.

The recalled product

Product
stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
Manufacturer
Howmedica Osteonics Corp.
Category
Medical Device — Orthopedic Implant / Surgical Trial
Hazard
Affected units
102

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • GTIN 00848486003753
  • Lot Number 26250421

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 2 recalled by Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Howmedica Osteonics Corp.

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Same hazard · incorrect marking

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