Agency classClass IIOur severity:High FDA (Devices)·Z-0472-2021·Announced 2020-11-25

Mako MICS Handpiece Recalled for Potential Bone Preparation Discrepancies

Stryker is recalling Mako MICS Handpieces due to a characterization issue that may cause unsuccessful checkpoint verification or bone cuts differing from the preoperative plan.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: The recall involves a medical device used in surgical procedures where a defect could lead to bone cuts differing from the preoperative plan, representing a risk of harm to patients, although no specific injuries or illnesses are reported in the source text.

Plain-English summary

Stryker is recalling the Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, due to a discovered characterization issue. The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO and to execute bone preparation during Mako Total Knee or Mako Partial Knee procedures using PKA Software Application 3.0 or later.

The issue may result in unsuccessful checkpoint verification when the Mako System attempts to verify the location of the saw blade prior to bone preparation. Additionally, the issue may cause a discrepancy during bone preparation in Mako Total Knee or Mako Partial Knee procedures where the surgeon uses a straight or angled saw attachment with the MICS Handpiece. This can lead to the surgeon making cuts during bone preparation that differ from the surgeon's preoperative plan.

The recall involves 367 units distributed worldwide, including the United States, Australia, Japan, Korea, the Netherlands, Chile, France, Germany, Luxembourg, and the UK. Healthcare providers and facilities should contact Stryker for further instructions on how to proceed with the affected devices.

The recalled product

Product: Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0 and later, and TKA 1.0 - Product Usage: The MICS Handpiece is attached to the distal end of the robotic arm and is used to register the RIO (Mako robot) and to…
Manufacturer: Mako Surgical Corporation
Category: Medical Device — Surgical Robotics
Hazard: surgical-error
device-malfunction
Affected units: 367

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 (20)

(01) 00848486030193 (21)<serial number>
Serial numbers: 4200052
4200095
4200112
4200117
4200119
4200167
4200190
4200193
4200202
4200203
4200204
4200226
4200233
4200235
4200248
4200250
4200257
4200269
4200270

Distribution

Distributed nationwide across the United States.

Same manufacturer · Mako Surgical Corporation

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Same hazard · surgical error