Intellijoint Navigation Systems Recalled for Potential Fire Risk
Intellijoint Surgical is recalling eight navigation systems because their workstations may contain a defective Apple battery that could overheat and cause a fire.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as Class II by the FDA, and the source identifies a fire safety risk due to a battery that may overheat. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
Intellijoint Surgical, Inc. is recalling eight Intellijoint Navigation Systems, including the Workstation G2 Configured, HIP Cart System, and HIP Portable System. The recall involves specific units distributed in the United States (California, Texas, Mississippi, New Jersey) and internationally (Singapore, Spain).
The recall is issued because the workstation component of these systems may contain a 15-inch MacBook Pro battery that is subject to a separate Apple battery recall. This specific battery defect may cause the unit to overheat, posing a fire safety risk.
The source text does not report any illnesses, injuries, or deaths associated with this recall. Users of the affected systems should stop using the workstation and contact Intellijoint Surgical for instructions on how to proceed.
The recalled product
- Product
- Intellijoint Navigation System: Workstation G2 Configured, REF: 000-0241; Intellijoint HIP Cart System, REF: 000-0250; Intellijoint HIP, Portable System, REF: 000-0249
- Manufacturer
- Intellijoint Surgical, Inc.
- Hazard
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- REF/UDI-DI/MacBook Serial Numbers: 000-0241/00628184002414/C02RP36YG8WP
- C02QPCF5G8WN 000-0250/00628184002506/C02RF44TG8WN
- C02QW25RG8WL
- C02QH355G8WM
- C02S22N9G8WP
- 000-0249/00628184002490/C02RQ3FUG8WN
- C02R4451G8WN
Distribution
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