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U.S. Department of Health and Human Services

Class 2 Device Recall Paragon 28

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  Class 2 Device Recall Paragon 28 see related information
Date Initiated by Firm May 18, 2022
Create Date July 25, 2022
Recall Status1 Open3, Classified
Recall Number Z-1458-2022
Recall Event ID 90478
Product Classification Plate, fixation, bone - Product Code HRS
Product Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
Code Information Lot # : HN2204123455; UDI/DI: 00889795053329
Recalling Firm/
Manufacturer		 Paragon 28, Inc.
14445 Grasslands Dr
Englewood CO 80112-7062
For Additional Information Contact Mandy Kinnee
888-728-1888
Manufacturer Reason
for Recall		 Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
FDA Determined
Cause 2		 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 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.
Quantity in Commerce 3 units
Distribution International distribution in the country of UK.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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