FDA Medical Device Recalls (openFDA)
Coltene Whaledent Inc: 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.
- Recall number
- Z-0376-2019
- Recalling firm
- Coltene Whaledent Inc
- 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.
- Status
- Terminated
- Initiated
- 2018-08-21
- Posted
- not on file
- Terminated
- 2020-04-10
- Reason
- ParaPost Plus Titanium Posts contain stainless steel post that are a size 4
- 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: tricia.cregger@coltene.com or Phone: 330-916-8817. If you should have additional questions, please contact Regulatory Affairs Manager, at 330-916-8904 and Tricia.Cregger@coltene.com.
- Quantity
- 30 packets
- Distribution
- US Distribution to states of: CA, IL, NV, NY, PA, and WA' and to country of: Canada.
- Lot, serial or model codes
- Batch I33012
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- ELR
- Firm FEI
- 2416455
- Firm city
- Cuyahoga Falls
- Firm state
- OH
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28