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Gyrus ACMI
Gyrus ACMI, LLC · Model 140971 · UDI-DI 00821925017696
ETB
Prescription
1
510(k) clearances
100
Adverse events
3
Recalls
26
Facilities
Description
APPLEBAUM INCUS REPLACEMENT 2.25 MM DENSE HYDROXYLAPATITE
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-03 | Grace Medical, Inc. | Due to incorrect functional length on device labeling. |
| 2020-07-14 | Olympus Corporation of the Americas | Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; se |
| 2020-07-14 | Olympus Corporation of the Americas | Mislabeled outer carton: packaged with the outer carton label stating the contents were the 70143662 Smart Piston but the inside package contents was the 70142158 Stapes Piston; se |
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