CLASS II ONGOING Device recall · Reported 3 Aug 2022 · FDA Enforcement Report
System: Baby Gorilla/Gorilla Plating System recalled by Paragon 28
Paragon 28 is recalling Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, distributed nationwide in the US. The recall was initiated on 18 May 2022 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1458-2022
- FDA event ID
- 90478
- Recalling firm
- Paragon 28, Englewood, CO
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 May 2022
- FDA classified
- 25 Jul 2022
- Reported
- 3 Aug 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Other Medical Devices
Timeline
| 18 May 2022 | Recall initiated by company | |
| 25 Jul 2022 | Classified by FDA | +68 days |
| 3 Aug 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
Product as listed by the FDA
Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
Where it was distributed
International distribution in the country of UK.
Questions about this recall
Is System: Baby Gorilla/Gorilla Plating System recalled?
Yes. Paragon 28 recalled System: Baby Gorilla/Gorilla Plating System on 18 May 2022. The recall is Class II and its status is Ongoing. Recall number Z-1458-2022.
Why was it recalled?
Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
Which lots are affected?
Lot # : HN2204123455; UDI/DI: 00889795053329
Where was it sold?
International distribution in the country of UK.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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