P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, I

FDA device recall Z-2758-2026 · posted 2026-07-17 · Open, Classified

Recall details

Recalling firm

Paragon 28, Inc.

Reason for recall

Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.

Action taken

Paragon 28 issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 6/22/2026 via email and courier. The notice explained the issue, risks associated with the use of the affected product, and requested the following: "Risk Manager Responsibilities: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, immediately locate and quarantine affected product in your inventory. a. Your Paragon 28 sales representative may remove and return the affected product from your facility on your behalf. b. Alternatively, you may directly return all affected product from your facility. i. Complete Attachment 1 Certificate of Acknowledgement for each return and send to CorporateQuality.PostMarket@zimmerbiomet.com. ii. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. iii. Mark RECALL on the outside of the returned cartons 3. If the product has been further distributed, provide your customers with this notice and ensure documentation. 4. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form shall be returned even if you do not have affected products at your facility. 5. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facility s documentation. 6. If you have further questions or concerns after reviewing this notice, please call 888-728-1888. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com. Surgeon Responsibilities: 1. Review this notification for awareness of the contents. 2. There are no specific patient monitoring instructions related to this recall that are recommended beyond your existing follow-up schedule. 3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. 4. Retain a copy of

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

HXI

Quantity affected

514 units

Distribution

US nationwide, Australia, Canada, The Netherlands, and New Zealand

Date initiated

2026-06-17

Date posted

2026-07-17

Location

Englewood, CO