Paragon 28, Inc. 14445 Grasslands Dr Englewood CO 80112-7062 Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.

Recommended Action

Per FDA guidance

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 mkinnee@paragon28.com. 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 (complaints@paragon28.com), or directly the FDA s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Distribution

As reported by FDA

IN