Recall Z-2228-2019— Intellijoint Surgical, Inc.

Name: FDA recall Z-2228-2019
Creator: U.S. Food and Drug Administration
Published: 2019-06-28

Class II · Terminated

Class II FDA medical device recall by Intellijoint Surgical, Inc., initiated 2019-06-28, terminated 2020-09-16. It names one FDA 510(k) clearance: K172849. Product: Workstation, G2, Configured (P/N 000-0241). Reason: Apple has determined that, in a limited number of older generation 15-inch MacBook Pro Units, the battery may overheat and pose a fire safety risk. To date, Intellijoint has distributed, 15-inch MacBook Pros which are the Workstation component (affected P/N 000-0241) in the Intellijoint HIP System..

Recalling firm: Intellijoint Surgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2019-06-28
Terminated: 2020-09-16
Firm location: Waterloo, N/A, Canada

510(k) clearances named in this recall

1 on FDA's record

K172849 — Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument TrayIntellijoint Surgical, Inc.·cleared 2017-11-16

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Workstation, G2, Configured (P/N 000-0241)

Reason for recall

Apple has determined that, in a limited number of older generation 15-inch MacBook Pro Units, the battery may overheat and pose a fire safety risk. To date, Intellijoint has distributed, 15-inch MacBook Pros which are the Workstation component (affected P/N 000-0241) in the Intellijoint HIP System.

Data sourced from openFDA. This site is unofficial and independent of the FDA.