ACTEON
SATELEC · Model TIP BS6 XXL M+ STERILE · UDI-DI 03609820879871
JDX
Prescription
1
510(k) clearances
176
Adverse events
2
Recalls
36
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.