FDAFDA · Food and drugs·Recall number Z-0472-2021

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).

Published November 25, 2020 · Recall initiated: October 23, 2020

Status when published: Completed — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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.

What to do

Voluntary: Firm initiated · Letter

Recall details

Manufacturer: Mako Surgical Corporation
Distributor: Worldwide distribution - US Nationwide distribution and the countries of Australia, Japan, Korea, Netherlands, and Chile, and France, Germany Luxembourg, and UK
Lot: (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 dev
Risk classification: Class II
Area (FDA): device
Country: United States

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