Reported Nov 25, 2020 · Completed
Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3.0 and later, PKA 3.0…
Mako Surgical Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Mako Surgical Corporation · 2555 Davie Rd Ste 110 · Davie, FL · 33317-7424
Is this the product you have?
- 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 UsageThe 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)
- Lot codes and dates
- (01) 00848486030193 (21)<serial number>
- Serial numbers
364 of 364 codes
420005242000954200112420011742001194200167420019042001934200202420020342002044200226420023342002354200248420025042002574200269420027042002884200293420030542003504200373420038442003874200391420039742003984200400420040942004364200457420045942004774200488420051242005404200548420055042005584200624420064542006534200666420071742007664200774420078542007894200801420080642008074200816420084342008564200868420090442009174201000
- Updated information submittedSerial
- numbers removed from 12/23/20 letter
420011242001174200202420141242014904201661
- reasonThese devices are still in scope and exhibit the issue. However, it was found that none of these devices were distributed to a customer. Therefore, they were removed from the attachment in the letter and are within Stryker control. Serial
- Numbers added to the recall letter
42092924209646420984142026294203963
- reasonThese devices were originally thought to be in Stryker control, but were shipped to customers. Serial
- Numbers added to the recall letter
420991742099224209924
- reasonThese devices were shipped to Stryker OUS distributor and were thought to be distributed to customers. (Firm later confirmed that the units are under Stryker control.)
- Amount recalled
- 367 units
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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