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U.S. Department of Health and Human Services

Class 2 Device Recall Workstation, G2, Configured (P/N 0000241)

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 Class 2 Device Recall Workstation, G2, Configured (P/N 0000241)see related information
Date Initiated by FirmJune 28, 2019
Date PostedAugust 08, 2019
Recall Status1 Terminated 3 on September 16, 2020
Recall NumberZ-2228-2019
Recall Event ID 83299
510(K)NumberK172849 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
ProductWorkstation, G2, Configured (P/N 000-0241)
Code Information Apple MacBook Serial Numbers: C02R4A0ZG8WN, C02R4CTLG8WN, C02R4CVYG8WN, C02R4CTHG8WN, C02R4CUZG8WN, C02R4CV6G8WN, C02R4CWZG8WN  Additional units discovered 09/18/2019: C02R4CQ5G8WN, C02R4CULG8WN, C02R4CVWG8WN, C02R4CWYG8WN, C02R4CQ6G8WN, C02R4CUPG8WN, C02R4CSSG8WN, C02R4CTQG8WN, C02R4CSZG8WN, C02R4CUSG8WN, C02R4CUXG8WN, C02R4CUQG8WN, C02R4CU0G8WN, C02R4A6PG8WN, C02R4CTMG8WN, 02R4CUNG8WN
FEI Number 3010822102
Recalling Firm/
Manufacturer		 Intellijoint Surgical, Inc.
60 Bathurst Dr Unit 1
Waterloo Canada
Manufacturer 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.
FDA Determined
Cause 2		Nonconforming Material/Component
ActionThe firm initiated the recall by email on 06/28/2019. The letter requested the distributor locate and return the MacBooks.
Quantity in Commerce23 units
DistributionIL, CA, NY, TX, RI, Australia
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = OLO
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