Mako Surgical Corporation Recall: Mako Integrated Cutting System (MICS) Handpiece, Catalog
Mako Surgical Corporation Recall: Mako Integrated Cutting System (MICS) Handpiece, Catalog is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Mako Surgical Corporation; Product: Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, P
| Recalling firm | Mako Surgical Corporation |
|---|---|
| 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 execute bone preparation during a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later). |
| Reason for recall | Stryker has discovered a characterization issue associated with the Mako Integrated Cutting System (MICS) Handpiece. 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 a Mako Total Knee or Mako Partial Knee procedure (PKA Software Application 3.0 or later). This issue may result in unsuccessful checkpoint verification when the Mako System attempts to verify the location of the saw blade prior to bone preparation. This issue may also cause a discrepancy during bone preparation in a Mako Total Knee or a Mako |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Completed |
| Distribution | Worldwide distribution - US Nationwide distribution and the countries of Australia, Japan, Korea, Netherlands, and Chile, and France, Germany Luxembourg, and UK |
| Recall initiated | 20201023 |
| Recall number | Z-0472-2021 |
| Category | device |
| State | FL |
| Country | United States |
$29/mo
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