Recall Z-1458-2022 ยท HRS Plate, Fixation, Bone
Paragon 28, Inc.
Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
| Date | May 18, 2022 |
| Status | Open, Classified |
| Reason | Incorrect labeling; There is potential that the drill packaging contains the incorrect part number. |
| 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 mkinnee@paragon28.com. 3. Return affe |
| Quantity | 3 units |
| Distribution | International distribution in the country of UK. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.