Restoris MCK Onlay Insert Extractor.
FDA Recall Z-2051-2018 · Posted 2018-06-01
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Recalling FirmMako Surgical Corporation
Recall StatusTerminated
Product CodeNPJ
Date Initiated2018-01-19
Date Terminated2020-09-16
Product Quantity575 units total (400 US, 175 OUS)
Reason for Recall
Possible hinge pin disassociation from the Mako Onlay Insert Extractor.
Firm Action
Customers were initially notified on approximately 01/19/2018, and again notified when the recall was expanded on 04/25/2018. Instructions included to inform all applicable individuals within the organization that need to be notified, complete and return the Recall Notification Business Reply Form, and make arrangements for return all affected products on hand.
On about 12/12/2018, Stryker expanded the scope of the recall to include two additional lot codes and notified customers via "URGENT MEDICAL DEVICE REMOVAL" letter. Instructions were the same as the original recall notification.
Root Cause
Under Investigation by firm
Distribution Pattern
Distributed domestically to AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, WI. Distributed internationally to Australia, China, Italy, Netherlands, Singapore, South Africa, Taiwan, Turkey, United Kingdom.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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