Paragon 28, Inc. recalls Custom Made Device Implant 6123 Navicular Cage Small Right Rev A

Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.

Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant

Paragon 28 issued an URGENT MEDICAL DEVICE RECALL to its consignees on 7/14/2026 via FedEx 2nd day. The notice explained the issue, potential risk, and requested the following: Distributors: "Your Responsibilities 1. Review this notification and ensure that affected team members are aware of the contents. 2. Immediately locate and quarantine affected product in your inventory. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Attachment 1 Inventory Return Certification Form for each return and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products available to return in your territory. b. Include a hardcopy of Attachment 1 in each carton of your return shipment for immediate processing. c. Mark RECALL on the outside of the returned cartons. 4. Retain a copy of your Inventory Return Certification and product return forms for your records in the event of a compliance audit of your facility. 5. 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." Risk Manager: "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, assist your Paragon 28 sales representative and quarantine all affected product. Your Paragon 28 sales representative will remove the affected product from your facility. 3. If the product has been further distributed, provide your customers with the field safety notice for hospitals 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. Retai

• FDA enforcement recordOfficial FDA database entry for Z-2971-2026
• FDA device classification · PLFOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3030The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Paragon 28, Inc.Search for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.