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Terminated

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.

FDA Recall Z-0376-2019 · Posted None

Recalling FirmColtene Whaledent Inc
Recall StatusTerminated
Product CodeELR
Date Initiated2018-08-21
Date Terminated2020-04-10
Product Quantity30 packets

Reason for Recall

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

Firm Action

The firm, Coltene, issued an "Urgent Medical Device Recall" Letter dated August 20, 2018 to the customers on August 21st via email with a delivery and read receipt requested. The letter described the product, problem and actions to be taken. The customers were instructed to return the product to Coltene/Whaledent Inc.; return any unused product and we will replace your product at no cost, and complete and return the Return Response Form via email: [email protected] or Phone: 330-916-8817. If you should have additional questions, please contact Regulatory Affairs Manager, at 330-916-8904 and [email protected].

Root Cause

Process control

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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