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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:113067

Ultrafill DBM labeled in part: TISSUENET Sterilized by T10^6 Description: UltraFill DBM Size: 1cc Product Code: RT53001 Donated Human Tissue Allograft SINGLE PATIENT USE ONLY FOR INTERNATIONAL USE ONLY See Package Insert for Additional Information TissueNet's Porcine DBM product line is used as a bone void filler

Official recall number

Z-0651-2013

Evidence summary

Product code
MQV
Recall status
Terminated
Event initiated
March 14, 2012
Root cause
Employee error
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0651-2013