Device product
Snowden-Pencer MIS DIAMOND-TOUCH DISSECTOR DIAMOND JAW 5MM, 32CM, RATCHETED, REF SP90-7071; endoscopic surgical device
Z-2425-2023
Product summary
- Event
- Event 92561
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 42 units
- Official record key
device-enforcement:Z-2425-2023
Official wording
Reason: Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.
Code information: UDI/DI 10885403160790, Lot Numbers: L22, B23, C23
Distribution pattern: US and Canada
Derived failure modes
-
Unknown
Specific lots of the product have the potential to exhibit cracking or breaking of the rotation knob due to the incorrect use of an adhesive in the manufacturing process.