Device product
Aligned Medical Solutions Spine Pack, REF: AMS4599(C, containing P 2 Cover Light Handle Blue STE, Sterile EO
Z-1619-2023
Product summary
- Event
- Event 92288
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 30 kits
- Official record key
device-enforcement:Z-1619-2023
Official wording
Reason: Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient
Code information: Lot #s 187143 and 188654; UDI: B098AMS4599C0
Distribution pattern: US: MA OUS: None
Derived failure modes
-
Unknown
Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient