Recall Z-1458-2022— Paragon 28, Inc.
Class II · Ongoing
Class II FDA medical device recall by Paragon 28, Inc., initiated 2022-05-18. FDA's recall record names no specific 510(k) clearance for this event. 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..
- Recalling firm
- Paragon 28, Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-05-18
- Firm location
- Englewood, CO, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.