Medical Device
Manufacturing
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Z-2228-2019Class II

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

Intellijoint Surgical Inc. / initiated 2019-06-28 / Terminated / root cause: manufacturing process

Intellijoint Surgical, Inc. began a recall of Workstation, G2, Configured (P/N 000-0241) on . FDA classified it as Class II and gives the reason as "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...". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number
Z-2228-2019
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Intellijoint Surgical Inc.
Product
Workstation, G2, Configured (P/N 000-0241)
Product code
OLO Orthopedic Stereotaxic Instrument
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.
Root cause tag
manufacturing process
FDA root cause
Nonconforming Material/Component
Action
The firm initiated the recall by email on 06/28/2019. The letter requested the distributor locate and return the MacBooks.
Quantity in commerce
23 units
Distribution
IL, CA, NY, TX, RI, Australia
Product codes and lots
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

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-2228-2019
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-2228-2019Class IITerminatedVoluntary: Firm initiated