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Recall Observatory FDA recall evidence

Device evidence

device-recall:cfres:175769

Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958

Official recall number

Z-0261-2020

Evidence summary

Product code
NDP
Recall status
Terminated
Event initiated
September 06, 2018
Root cause
Nonconforming Material/Component
Source snapshot
5482458777762b1480c71ac49b2913b9c7984bb55aac66a4315d018da7cfed2c
Product
Z-0261-2020

Field note

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