EBI OsteoGen™ Implantable Bone Growth Stimulator
EBI, LLC · Model 10-1348M · UDI-DI 00812301020102
LOE
Prescription
0
510(k) clearances
140
Adverse events (2 deaths)
4
Recalls
5
Facilities
Description
OSTEOGEN-40/M
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-02-19 | Zimmer Biomet, Inc. | Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met. |
| 2018-02-19 | Zimmer Biomet, Inc. | Lack of adequate validation and controls to ensure that product cleanliness parameters were consistently met. |
| 2017-04-20 | EBI Patient Care, Inc. | Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity |
| 2017-04-20 | EBI Patient Care, Inc. | Zimmer Biomet is conducting a medical device field action for the SpF PLUS-Mini and SpF XL IIB Implantable Spinal Fusion Stimulator products due to higher than allowed cytotoxicity |
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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.