Paragon 28 recalls a specific foot implant model due to elevated oxygen levels potentially reducing material strength. Affected units include Lot AOCIA6123.
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
“Paragon 28 Custom Foot Implant Recall: Elevated Oxygen Risk.” GovInfoNow, updated September 14, 2026. https://govinfonow.com/recall/697909-paragon-28-custom-foot-implant-recall-elevated-oxygen-risk. Based on FDA recall #Z-2972-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2972-2026%22&limit=1).
The FDA announced on July 10, 2026, that Paragon 28, Inc. is recalling one Custom Made Device Implant foot implant due to elevated oxygen levels that may reduce material ductility. The agency issued recall number Z-2972-2026 for the Class III device distributed in Montana.
How to tell if you have it
Brand: Paragon 28
Product: Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant
Lot Number: AOCIA6123
Quantity: 1 unit
The hazard
According to the FDA, the device was recalled because it contained an elevated oxygen level in excess of the allowable limit. The agency stated that these elevated oxygen levels may contribute to reduced material ductility.
Context
GovInfoNow's records show Paragon 28, Inc. has had 9 other recalls on record since December 19, 2017. Recent brand recalls include a June 17, 2026 packaging breach risk and an October 13, 2025 thread depth issue for the Phantom Fibula Nail. Other recent recalls of similar products include Howmedica TRIATHLON Hinge Insert Recall (July 30, 2026), Howmedica TRIDENT 0° POLY INSERT 28mm ID 620-00-28D (July 30, 2026), and Howmedica OMNIFIT Series I Acetabular Insert Recall (July 30, 2026).
How to tell if you have this one
Check for the model number 6123N R and lot number AOCIA6123 on the implant. This specific custom foot implant was sold under the Paragon 28 brand.
Brand
Paragon 28
Category
Medical device
FDA recall event · 2 products
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
Classification
Class III
Status
Ongoing
Distribution
US Nationwide distribution i the state of MT.
Recall number
Product, codes & lots
Quantity
Z-2971-2026
Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant; Lot Number AOCIA6123
1
Z-2972-2026
Custom Made Device Implant 6123 Navicular Cage Nominal Right Rev A, Model/Catalog Number 6123N R; foot implant; Lot Number AOCIA6123
1 unit
Based on the official FDA remedy
What to do — step by step
Check Implant Details
Look for the model number 6123N R and lot number AOCIA6123 on the implant.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “US Nationwide distribution i the state of MT.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 47 days after the firm started it.
1Firm started the recall
2FDA classified it Class III
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
Dates from the agency record only; steps without a date are left out.
The recall states elevated oxygen levels may reduce material strength, but no specific injury risk is mentioned. The hazard is not severe enough to require immediate action.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-2972-2026 (July 10, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2972-2026 to see it in context.
Plain-language summary written by qwen3:4b on September 14, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.