Paragon 28 Gorilla Plating System Drill Recalled for Incorrect Packaging Label
Paragon 28, Inc. has recalled Baby Gorilla/Gorilla Plating System drills (Ref: P99-100-2816) because the drill packaging may contain incorrect part numbers.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving a labeling error with no reported illnesses, injuries, or hospitalizations. The hazard is theoretical and falls under minor labeling errors as defined in the severity rubric.
Plain-English summary
Paragon 28, Inc. has issued a recall of the Baby Gorilla/Gorilla Plating System drills (Reference: P99-100-2816). The recall affects 3 units with lot number HN2204123455. These are stainless steel drills measuring 2.4 x 160mm.
The affected units were distributed internationally in the United Kingdom and are identified by UDI/DI code 00889795053329.
The recall was issued because the drill packaging may contain incorrect part numbers. Healthcare facilities that received these devices should verify the part number on the packaging before use.
The recalled product
- Product
- Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
- Manufacturer
- Paragon 28, Inc.
- Category
- Medical Device
- Hazard
- Affected units
- 3
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # : HN2204123455
- UDI/DI: 00889795053329
Distribution
Distribution scope not specified by the agency.
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