ACTEON
SATELEC · Model TIP RHS2H M+ STERILE · UDI-DI 03609820879901
JDX
Prescription
10
510(k) clearances
176
Adverse events
2
Recalls
38
Facilities
Description
Osteotomy, osteoplasty, decorticating, drilling, shaping and smoothing of the bones and teeth in various surgical procedures, including but not limited to general, orthopedic, otolaryngologic, maxillofacial, oral, hand/foot, neurosurgery, spinal, and plastic/reconstructive surgery.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-06-04 | Zimmer Biomet, Inc. | The products do not have sufficient data to support the labeled shelf life of 10 years. |
| 2019-06-04 | Zimmer Biomet, Inc. | The products do not have sufficient data to support the labeled shelf life of 10 years. |
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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.