Mako Surgical recalls specific MICS Handpiece models with software versions THA 3.0 and later that may cause bone preparation errors during knee surgery. Affected units have serial numbers listed in the recall notice.
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 Partial Knee procedure in which the surgeon uses a straight or angled saw attachment with the MICS Handpiece. The surgeon may make cuts during bone preparation that differ from the surgeon s preoperative plan.
Mako Surgical is recalling certain MICS Handpieces with software versions THA 3.0 and later that may cause bone preparation errors during knee surgery. This could lead to cuts differing from the surgeon's preoperative plan.
The handpiece has a characterization issue that may cause unsuccessful checkpoint verification before bone preparation. This could result in the surgeon making cuts that differ from their preoperative plan during knee surgery.
Surgeons using the Mako Total Knee or Mako Partial Knee systems with the recalled handpieces. The risk is primarily for medical professionals performing these procedures.
Check for serial numbers listed in the recall notice (4200052, 4200095, and other numbers provided). The handpiece has software version THA 3.0 or later for Total Knee procedures and PKA 3.0 or later for Partial Knee procedures.
Verify the software version on your MICS Handpiece. If it's THA 3.0 or later for Total Knee procedures or PKA 3.0 or later for Partial Knee procedures, it may be affected.
Software versions THA 3.0 and later for Total Knee procedures and PKA 3.0 and later for Partial Knee procedures.
Check the serial number against the list provided in the recall notice. Affected units have specific serial numbers listed in the record.
The recall record shows no remedy is specified. Affected units may need to be checked by the manufacturer.
We’ve drafted a message you can send Mako Surgical to request your refund or repair — edit it as you like.
Subject: Recall Z-0472-2021 — Mako Surgical Mako Surgical Hello, I own a Mako Surgical that is covered by recall Z-0472-2021 from Mako Surgical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
