FDA Medical Device Recalls (openFDA)
Ivoclar Vivadent, Inc.: Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
- Recall number
- Z-0665-2018
- Recalling firm
- Ivoclar Vivadent, Inc.
- Product
- Heliomolar Refill 20x0.25g 110/A1, Product code 541501AN, Catalog number 541501
- Status
- Terminated
- Initiated
- 2017-08-03
- Posted
- not on file
- Terminated
- 2018-08-28
- Reason
- Complaints were filed claiming the material consistency was too soft and too sticky in comparison to its usual consistency, causing unexpected handling for the user during packing and contouring.
- Root cause
- Nonconforming Material/Component
- Action
- The firm sent letters to consignees on August 3, 2017 instructing them to segregate the recalled product and arrange for a replacement of stock.
- Quantity
- 2,153 units
- Distribution
- US and Canada
- Lot, serial or model codes
- Batch: V35109 Exp. date: 01.10.2020; Batch: V40817 Exp. date: 13.11.2020; Batch: V48597 Exp. date: 30.12.2020; Batch: V48938 Exp. date: 31.12.2020 Batch: W12251 Exp. date: 31.03.2021
- 510(k) numbers
- ["K884588"]
- PMA numbers
- not on file
- Product code
- EBF
- Firm FEI
- 1316092
- Firm city
- Amherst
- Firm state
- NY
- 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