Restoris MCK Onlay Insert Extractor.

FDA device recall Z-2051-2018 · posted 2018-06-01 · Terminated

Recall details

Recalling firm

Mako Surgical Corporation

Reason for recall

Possible hinge pin disassociation from the Mako Onlay Insert Extractor.

Action taken

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

Status

Terminated

Product code

NPJ

Quantity affected

575 units total (400 US, 175 OUS)

Distribution

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,

Date initiated

2018-01-19

Date posted

2018-06-01

Date terminated

2020-09-16

Location

Davie, FL

Related 510(k) clearances