FDA Medical Device Recalls (openFDA)
Ultradent Products, Inc.: Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
- Recall number
- Z-3216-2017
- Recalling firm
- Ultradent Products, Inc.
- Product
- Ultradent Products, Inc. Paper Points, Size 30 PN #1555, 200 per container, sterile. Product Usage: The product is used to assure that all moisture is removed from the root canal before the obturation procedure begins.
- Status
- Terminated
- Initiated
- 2017-08-04
- Posted
- not on file
- Terminated
- 2018-01-04
- Reason
- The barcode label was placed underneath the sterile barrier and the product was re-wrapped.
- Root cause
- Process change control
- Action
- The recalling firm issued letters dated August 4, 2017 via certified mail,2-day delivery mail, or email on August 4, 2017. The letter identified the affected product, problem, and actions to be taken. For questions contact Regulatory Affairs Specialist at Ultradent Products, Inc.
- Quantity
- 210 units
- Distribution
- Distribution was nationwide. Foreign distribution was made to Canada, Bulgaria, Namibia, New Zealand and Germany. There was no military /government distribution.
- Lot, serial or model codes
- Lot numbers BC8MS, BCBHD, and BDQJ6
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- EKN
- Firm FEI
- 1718912
- Firm city
- South Jordan
- Firm state
- UT
- 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