Z-0376-2019Class II

ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are...

Name: Z-0376-2019 ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are...
Creator: Coltene Whaledent Inc
Published: 2018-08-21
License: https://open.fda.gov/license/

Coltene /Whaledent AG / initiated 2018-08-21 / Terminated / root cause: manufacturing process

FDA source

Coltene Whaledent Inc began a recall of ParaPost Plus 25 Titanium Alloy Spiral Vented and Serrated Posts Catalog Number: P2845B Dental Posts are implanted into teeth for dental restoration purposes... on 2018-08-21. FDA classified it as Class II and gives the reason as "ParaPost Plus Titanium Posts contain stainless steel post that are a size 4". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0376-2019
Classification: Class II
Status: Terminated
Initiated: 2018-08-21
Posted: 2018-11-02
Terminated: 2020-04-10
Recalling firm: Coltene /Whaledent AG
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.
Product code: ELR Post, Root Canal
Reason for recall: ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
Root cause tag: manufacturing process
FDA root cause: Process control
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].
Quantity in commerce: 30 packets
Distribution: US Distribution to states of: CA, IL, NV, NY, PA, and WA' and to country of: Canada.
Product codes and lots: Batch I33012

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0376-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0376-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-14	2018-11-02

Product code ELR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)