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GalaFLEX 3DR
Tepha, Inc. · Model 100043-05 · UDI-DI 00810054980049
OOD
Prescription
1
510(k) clearances
1,213
Adverse events (7 deaths)
1
Recalls
12
Facilities
Description
GalaFLEX 3DR Scaffold, 7.5 cm x 21.0 cm, Large Oval (Contents: 1)
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-11-21 | Tepha Incorporated | Endotoxin values from testing of retains slightly exceeded the established specification. |
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