medical MODERATE Updated 2026-06-10

Grace Medical, Inc. recalls TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/

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Recalled Product

TITANIUM/FLUOROPLASTIC PISTON 0.6MM DIA X 3.75MM L Model/Catalog Number: 409-375 Product Description: Stapes Prosthesis

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Hazard / Issue

Due to incorrect functional length on device labeling.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Model/Catalog Number: 409-375 UDI code: (01)00844505000772(10)122927(17)310301 Lot Number: 122927

✅ 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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