Z-2971-2026Class III

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

Name: Z-2971-2026 Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Creator: Paragon 28, Inc.
Published: 2026-07-10
License: https://open.fda.gov/license/

Paragon 28 / initiated 2026-07-10 / Open, Classified

FDA source

Paragon 28, Inc. began a recall of Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant on 2026-07-10. FDA classified it as Class III and gives the reason as "Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2971-2026
Classification: Class III
Status: Open, Classified
Initiated: 2026-07-10
Posted: 2026-08-14
Recalling firm: Paragon 28
Product: Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Product code: PLF Bone Wedge
Reason for recall: Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
FDA root cause: Under Investigation by firm
Action: 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 [email protected]. 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 [email protected]." 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 [email protected]. This form shall be returned even if you do not have affected products at your facility. 5. Retai
Quantity in commerce: 1
Distribution: US Nationwide distribution i the state of MT.
Product codes and lots: Lot Number AOCIA6123

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2971-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2971-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14
Z-2972-2026	Class III	Ongoing	Voluntary: Firm initiated	2026-08-26	2026-08-14

Product code PLF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-12. View this recall on fda.gov (opens on fda.gov)