Stryker Mako Surgical System Software Error Affects Knee and Hip Replacements
Stryker Orthopaedics is recalling Mako surgical system software used for knee and hip replacement procedures due to a software error that causes treatment delays when switching between surgical applications without proper system restart.
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: FDA Class II recall affecting surgical systems used during active procedures. The software error that causes treatment delays in a surgical setting represents a real risk of harm, despite no injuries having been reported to date.
Plain-English summary
Stryker Orthopaedics is recalling application software for the Mako 3.0 and Mako 3.1 surgical systems used in orthopedic procedures. The recall affects software versions for Total Knee Arthroplasty (TKA), Partial Knee Arthroplasty (PKA), and Total Hip Arthroplasty (THA) procedures.
The issue involves Software Error #3 (SE3) that occurs when switching between surgical applications (for example, from knee to hip replacement procedures) without first performing a proper Mako System shutdown and restart. This error results in delays in surgical treatment.
The recalled software has been distributed worldwide, including across the United States and 34 other countries. Approximately 40 units are affected.
Surgeons and hospital staff should follow proper shutdown and restart procedures when switching between applications to prevent the error. Affected facilities should contact Stryker Orthopaedics for further instructions.
The recalled product
- Product
- Total Knee Arthroplasty (TKA) 2, Total Knee Arthroplasty (TKA) 1, Partial Knee Arthroplasty (PKA) 3, Total Hip Arthroplasty (THA) 4.0, 4.1 on Mako 3.0, 3.1 Software: TKA 2.0.de.1+TKA 1.0.1.de.1+PKA3.0.2.de. Application Part Number: 700002190743-03
- Manufacturer
- Stryker Orthopaedics
- Category
- Medical Device — Surgical System
- Affected units
- 40
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 (3)
- AB
- AC
- & AD.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 recalled by Stryker Orthopaedics 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 6 products in this recall →Related recalls
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