medical LOW RISK Updated 2026-08-26

Paragon 28, Inc. recalls Custom Made Device Implant 6123 Navicular Cage Nominal Right

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Recalled Product

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

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Hazard / Issue

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

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot Number AOCIA6123

✅ What Should You Do?

  1. 1Contact your healthcare provider immediately to discuss this recall.
  2. 2Stop using the device if it is safe to do so, and contact your provider.
  3. 3Follow the manufacturer's remedy instructions provided in the recall notice.
  4. 4Report device problems to FDA MedWatch or call 1-800-FDA-1088.

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