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GalaFLEX LITE
Tepha, Inc. · Model 100027-34 · UDI-DI 00810054980803
OOD
Prescription
10
510(k) clearances
1,235
Adverse events (7 deaths)
1
Recalls
12
Facilities
Description
GalaFLEX LITE Scaffold, 25.0 cm, Circle
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-11-21 | Tepha Incorporated | Endotoxin values from testing of retains slightly exceeded the established specification. |
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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.