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Isodur®
Aesculap AG · Model NK772K · UDI-DI 04046963973070
OQG
Prescription
10
510(k) clearances
673
Adverse events
2
Recalls
119
Facilities
Description
ISODUR PROSTHESIS HEAD 12/14 40MM XL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-06-16 | Conformis, Inc. | 30mm screws were labeled as 25mm screws. |
| 2013-01-24 | Stelkast Co | Firm was made aware of incidents relating to the difficulty of properly engaging and securing the Cross-Over 36mm liner into the Cross-Over shell. |
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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.