Z-1458-2022Class II

Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel...

Name: Z-1458-2022 Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel...
Creator: Paragon 28, Inc.
Published: 2022-05-18
License: https://open.fda.gov/license/

Paragon 28 / initiated 2022-05-18 / Open, Classified / root cause: labeling and UDI

FDA source

Paragon 28, Inc. began a recall of Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm on 2022-05-18. FDA classified it as Class II and gives the reason as "Incorrect labeling; There is potential that the drill packaging contains the incorrect part number". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1458-2022
Classification: Class II
Status: Open, Classified
Initiated: 2022-05-18
Posted: 2022-07-25
Recalling firm: Paragon 28
Product: Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
Product code: HRS Plate, Fixation, Bone
Reason for recall: Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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.
Quantity in commerce: 3 units
Distribution: International distribution in the country of UK.
Product codes and lots: Lot # : HN2204123455; UDI/DI: 00889795053329

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1458-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1458-2022	Class II	Ongoing	Voluntary: Firm initiated	2022-08-03	2022-07-25

Product code HRS

The FDA recall record names no cleared device, and no clearance has been matched to it.

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)