Paragon 28 Navicular Cage Implant Recall
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Paragon 28, Inc. is recalling one Custom Made Device Implant 6123 Navicular Cage Small Right Rev A due to elevated oxygen levels.
What this FDA recall tells you, and what most readers miss
This notice was issued by FDA on September 9, 2026 and geographically references United States. The FDA classifies this as a Class III recall, with the stated reason "Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.", distributed us nationwide distribution i the state of mt.. FDA recall classes run from I (reasonable probability of serious harm) to III (unlikely to cause harm), so the class number is the fastest way to gauge severity here. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.
Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, medical-device.
What Happened
Paragon 28, Inc. initiated a voluntary recall of a foot implant device after it was determined to have an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
Which Products Are Affected
The recall affects one unit of the Custom Made Device Implant 6123 Navicular Cage Small Right Rev A (Model/Catalog Number 6123S R), lot number AOCIA6123. The product is a foot implant distributed nationwide in the United States, including the state of MT. The recall number is Z-2971-2026.
What You Should Do
Consumers should follow instructions provided in the firm's notification letter regarding the recalled device.
Why This Matters
This Class III recall involves a single device where the violation is not likely to cause adverse health consequences.
Source
FDA recall Z-2971-2026, report date 20260826.
Original source: FDA Official Notice ↗
Related FDA Recalls
All FDA Recalls →Nationwide notices with similar length or severity timing 8
Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.
Similar body length
Nearest notices by article body length (900 characters here).
Similar severity timing
Same severity (low) notices issued closest in time to September 9, 2026.
Frequently Asked Questions
Common questions about this FDA recall.