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AESCULAP
Aesculap AG · Model OL405R · UDI-DI 04038653178469
GAC
Prescription
2
510(k) clearances
32
Adverse events
1
Recalls
180
Facilities
Description
FOMON Bone File, 8 1/2" (215 mm), double ended, serrated (cross), width: 6,50 mm, 7,50 mm
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2011-12-29 | Stryker Howmedica Osteonics Corp. | Stryker Orthopaedics has become aware of the potential for the above noted Accolade Rasp Handle Assembly to fracture upon use. |
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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.