Baby Gorilla/Gorilla Plating System recallZ-1458-2022 · Paragon 28, Inc. · initiated May 18, 2022
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Paragon 28, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
FDA root cause category: Under Investigation by firm
What the company is doing
Initial communication was made on May 18, 2022 via E-Mail to inform the consignee about the recall. On June 10, 2022, a "Urgent Medical Device Recall" notice was sent via E-mail to affected consignee. Paragon 28 asked the consignee to take the following actions: 1. Review physical inventory of product in your control or at a hospital/health care facility within your region and any affected product that is identified, discontinue use, quarantine and do not distribute any further. 2. Complete the attached Medical Device Recall Response form and return to [email protected]. 3. Return affected devices immediately using the provided return label (attached) and include a copy of the Medical Device Recall Response form. Paragon28, Attn: Recalls 14445 Grasslands Dr. Englewood, CO 80112 4. Report any adverse reactions or quality problems experienced with the use of this product to Paragon 28 ([email protected]), or directly the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
Recall details
- Recall number
- Z-1458-2022
- Status
- Open, Classified
- Initiated by the company
- May 18, 2022
- Recalling firm
- Paragon 28, Inc.
- Quantity
- 3 units
- Product code
- HRS
- Distribution
- International distribution in the country of UK.
Product description
Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
Code information (models, lots, serial numbers)
Lot # : HN2204123455; UDI/DI: 00889795053329
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Baby Gorilla®/Gorilla® Plating System P99-100-2416Paragon 28, Inc. · BIT, DRILL1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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