Medical device recalls Moderate risk

Coltene Whaledent Inc recalls ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into…

Recall date
August 21, 2018
Source
U.S. Food & Drug Administration (FDA) — enforcement report
Recall number
Z-0376-2019
FDA classification
Class II
Brand / firm
Coltene Whaledent Inc
Sold / distributed
US Distribution to states of: CA, IL, NV, NY, PA, and WA' and to country of: Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.

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