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Recall Observatory FDA recall evidence

Device product

ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes. The normal procedure requires a hole to be drilled into the tissue of a tooth with an intraoral drill prior to installation.

Z-0376-2019

August 21, 2018

Class II

Product summary

Firm
Coltene Whaledent Inc
Event
Event 81065
Status
Terminated
Classification
Class II
Quantity
30 packets
Official record key
device-enforcement:Z-0376-2019

Official wording

Reason: ParaPost Plus Titanium Posts contain stainless steel post that are a size 4

Code information: Batch I33012

Distribution pattern: US Distribution to states of: CA, IL, NV, NY, PA, and WA' and to country of: Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    ParaPost Plus Titanium Posts contain stainless steel post that are a size 4