Workstation, G2, Configured (P/N 000-0241)
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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2228-2019 | Class II | Terminated | Voluntary: Firm initiated |
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