Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1912-2024 — 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.fr.1+TKA 1.0.1.fr.1+PKA3.0.2.fr. Application Part Number: 700002190743-04

U.S. FDA — Device Enforcement · United States · 2024-04-15 · Class II

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Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-1912-2024
Date of alert
2024-04-15
Country / jurisdiction
United States
Risk level
Class II
Risk type
recall
Brand
Stryker Orthopaedics
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
07613327629095
Reported risk: Application software intended to be deployed on Mako 3.0, part number 209999, and Mako 3.1, part number 219999, observed an increase in the Software Error #3 (SE3) error code when a Mako System shutdown or a Mako System restart is not performed prior to switching between applications (i.e. TKA to THA), resulting in delay in treatment
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

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