Recall archive / FDA device enforcement
Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Dri... — FDA record Z-1458-2022
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 18, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
- Reason
- Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
- Classification
- Class II
- Recalling firm
- Paragon 28, Inc.
- Quantity
- 3 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1458-2022
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot # : HN2204123455; UDI/DI: 00889795053329 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
International distribution in the country of UK.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Aug 3, 2022
- Recall initiation date
- May 18, 2022
- Center classification date
- Jul 25, 2022
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.