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GYRUS ACMI, INC
Gyrus ACMI, LLC · Model 140066 · UDI-DI 00821925027084
ETA
Prescription
1
510(k) clearances
93
Adverse events
2
Recalls
25
Facilities
Description
FLUOROPLASTIC PISTON 4.0 MM FUNCTIONAL LENGTH 0.8MM PISTON DIA. X 0.6 MM ID FLUOROPLASTIC
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2013-08-23 | Medtronic Xomed, Inc. | One lot of the product was assembled using the Cam Head version of the same prosthesis instead of the Round head Shaft. |
| 2011-04-27 | Heinz Kurz GmbH Medizintechnik | Outer package labels product .75 mm longer than actual size. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.