Workstation, G2, Configured (P/N 000-0241)
FDA device recall Z-2228-2019 · posted 2019-08-08 · Terminated
Recall details
- Recalling firm
- Intellijoint Surgical, Inc.
- 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.
- Action taken
- The firm initiated the recall by email on 06/28/2019. The letter requested the distributor locate and return the MacBooks.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- OLO
- Quantity affected
- 23 units
- Distribution
- IL, CA, NY, TX, RI, Australia
- Date initiated
- 2019-06-28
- Date posted
- 2019-08-08
- Date terminated
- 2020-09-16
- Location
- Waterloo, Canada
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray (K172849) | Intellijoint Surgical, Inc. | 2017-11-16 |