Z-1458-2022 Class II Ongoing
FDA device recall Z-1458-2022 was initiated by Paragon 28, Inc. on May 18, 2022 and is designated Class II. Reason for recall: Incorrect labeling; There is potential that the drill packaging contains the incorrect part number. The recall status is ongoing. Affected quantity: 3 units.
Recall Details
- Product Type
- Devices
- Report Date
- August 3, 2022
- Initiation Date
- May 18, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3 units
Product Description
Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
Reason for Recall
Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
Distribution Pattern
International distribution in the country of UK.
Code Information
Lot # : HN2204123455; UDI/DI: 00889795053329