Mako Integrated Cutting System (MICS) Handpiece, Catalog Number 209063, Software Version#: THA 3....
FDA Device Recall #Z-0472-2021 — Class II — October 23, 2020
Recall Summary
| Recall Number | Z-0472-2021 |
| Classification | Class II — Moderate risk |
| Date Initiated | October 23, 2020 |
| Status | Completed |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Mako Surgical Corporation |
| Location | Davie, FL |
| Product Type | Devices |
| Quantity | 367 units |
Product Description
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 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.
Distribution Pattern
Worldwide distribution - US Nationwide distribution and the countries of Australia, Japan, Korea, Netherlands, and Chile, and France, Germany Luxembourg, and UK
Lot / Code Information
(01) 00848486030193 (21)<serial number>, Serial numbers: 4200052, 4200095, 4200112, 4200117, 4200119, 4200167, 4200190, 4200193, 4200202, 4200203, 4200204, 4200226, 4200233, 4200235, 4200248, 4200250, 4200257, 4200269, 4200270, 4200288, 4200293, 4200305, 4200350, 4200373, 4200384, 4200387, 4200391, 4200397, 4200398, 4200400, 4200409, 4200436, 4200457, 4200459, 4200477, 4200488, 4200512, 4200540, 4200548, 4200550, 4200558, 4200624, 4200645, 4200653, 4200666, 4200717, 4200766, 4200774, 4200785, 4200789, 4200801, 4200806, 4200807, 4200816, 4200843, 4200856, 4200868, 4200904, 4200917, 4201000, 4201040, 4201068, 4201089, 4201102, 4201103, 4201121, 4201167, 4201218, 4201236, 4201238, 4201253, 4201296, 4201302, 4201366, 4201367, 4201376, 4201385, 4201408, 4201412, 4201442, 4201452, 4201454, 4201477, 4201490, 4201630, 4201661, 4201714, 4201752, 4201829, 4201831, 4201851, 4202009, 4202020, 4202038, 4202044, 4202062, 4202063, 4202122, 4202146, 4202162, 4202175, 4202315, 4202333, 4202626, 4202631, 4202659, 4202729, 4202742, 4202882, 4202987, 4203180, 4203198, 4203289, 4203424, 4203441, 4203649, 4203709, 4203728, 4203730, 4203731, 4203736, 4203807, 4203826, 4204015, 4204164, 4204389, 4204448, 4204539, 4204553, 4204577, 4204673, 4204812, 4204934, 4205093, 4205190, 4205380, 4205426, 4206219, 4206271, 4209023, 4209025, 4209044, 4209045, 4209046, 4209065, 4209066, 4209067, 4209068, 4209071, 4209149, 4209151, 4209155, 4209156, 4209157, 4209162, 4209164, 4209166, 4209167, 4209171, 4209185, 4209189, 4209210, 4209211, 4209213, 4209220, 4209244, 4209250, 4209252, 4209255, 4209256, 4209259, 4209261, 4209262, 4209267, 4209268, 4209271, 4209298, 4209299, 4209303, 4209304, 4209306, 4209308, 4209312, 4209317, 4209318, 4209345, 4209346, 4209357, 4209360, 4209363, 4209364, 4209365, 4209387, 4209388, 4209389, 4209398, 4209441, 4209443, 4209460, 4209463, 4209464, 4209466, 4209471, 4209472, 4209473, 4209474, 4209475, 4209476, 4209477, 4209486, 4209487, 4209491, 4209493, 4209494, 4209495, 4209496, 4209500, 4209519, 4209522, 4209526, 4209529, 4209531, 4209532, 4209533, 4209535, 4209541, 4209542, 4209543, 4209546, 4209597, 4209598, 4209599, 4209600, 4209601, 4209602, 4209604, 4209605, 4209606, 4209607, 4209608, 4209609, 4209610, 4209611, 4209612, 4209613, 4209614, 4209615, 4209616, 4209621, 4209628, 4209632, 4209634, 4209635, 4209637, 4209639, 4209640, 4209647, 4209667, 4209671, 4209685, 4209694, 4209698, 4209734, 4209764, 4209771, 4209774, 4209775, 4209776, 4209777, 4209778, 4209779, 4209780, 4209781, 4209782, 4209783, 4209784, 4209785, 4209786, 4209787, 4209788, 4209789, 4209790, 4209791, 4209792, 4209793, 4209794, 4209795, 4209796, 4209797, 4209798, 4209799, 4209800, 4209801, 4209802, 4209803, 4209804, 4209805, 4209806, 4209807, 4209808, 4209809, 4209810, 4209811, 4209812, 4209813, 4209814, 4209815, 4209816, 4209817, 4209818, 4209819, 4209820, 4209821, 4209822, 4209823, 4209834, 4209849, 4209859, 4209860, 4209863, 4209927, 4209928, 4209929, 4209930, 4209931, 4209932, 4209933, 4209934, 4209935, 4209936, 4209937, 4209938, 4209939, 4209940, 4209941, 4209942, 4209943, 4209945, 4209946, 4209947, 4209948, 4209949, 4209950, 4209951, 4209952, 4209954, 4209955, 4209956, 4209957, 4209959, 4209960, 4209961, 4209962, 4209963, 4209964, 4209965, 4209966, 4209967, 4209968, 4209969, 4209985, 4209986, 4209987, 4209988 Updated information submitted: Serial numbers removed from 12/23/20 letter: 4200112, 4200117, 4200202, 4201412, 4201490, 4201661; reason: These 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: 4209292, 4209646, 4209841, 4202629, 4203963; reason: These devices were originally thought to be in Stryker control, but were shipped to customers. Serial Numbers added to the recall letter: 4209917, 4209922, 4209924; reason: These 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.)
Other Recalls from Mako Surgical Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1735-2022 | Class II | Stryker USB Converter, Polaris Spectra Camera, ... | Aug 8, 2022 |
| Z-2745-2020 | Class II | Mako Hip End Effector, Variable Angle Catalog ... | Jul 9, 2020 |
| Z-1823-2019 | Class II | 2.7 Degree Angled Sagittal Saw attachment (Mako... | Apr 25, 2019 |
| Z-1824-2019 | Class II | 2.7 Degree Straight Sagittal Saw attachment (Ma... | Apr 25, 2019 |
| Z-2924-2018 | Class II | Stryker Mako Vizadisc Knee Procedure Tracking Kit | Jul 24, 2018 |
Frequently Asked Questions
A software recall means the device's embedded software or firmware has a defect that could affect its performance or safety. Many software recalls are corrected through firmware updates that can be applied without physically replacing the device. For implantable devices, the update may be delivered wirelessly during a routine clinic visit. For external devices, the manufacturer may provide updated software files or replacement units. Contact your healthcare provider to determine whether your specific device and software version are affected and what action is recommended.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.