FDA Medical Device Recalls (openFDA)
CMP Industries, Llc: IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface
- Recall number
- Z-2098-2016
- Recalling firm
- CMP Industries, Llc
- Product
- IMPAK ELASTIC ACRYLIC RESIN POWDER & LIQUID, SHADE TRANSPARENT, CONTENTS: 454 gm Powder + 325ml Liquid, REF 3746, Rx ONLY; Indicated for relining a denture surface
- Status
- Terminated
- Initiated
- 2016-04-28
- Posted
- not on file
- Terminated
- 2018-05-25
- Reason
- Possible presence of foreign material (rust).
- Root cause
- Material/Component Contamination
- Action
- On April 28, 2016, Nobilium, Division of CMP Industries LLC distributed Urgent Recall notices and Response Forms to their customers via courier service. Customers were advised to immediately examine inventory and to quarantine product subject to the recall. In addition, if customers further distributed the product, please identify your customers and notify them at once of this product recall. Your notification to your customers may be enhanced by including a copy of the notice. If customers have any of the product in their possession subject to recall, please contact the firm by calling John Nicpon at 518-434-3147, ext. 144. Hours of operation are Monday - Friday 8-4:30 pm, EST. Return completed recall response forms to nicpon@nobilium.com.
- Quantity
- 77 units Total
- Distribution
- Domestic - MI, MN, NJ, NM, NY & PA; International - Canada
- Lot, serial or model codes
- Lot Number: 79943 Expiration Date: March 2021
- 510(k) numbers
- ["K033020"]
- PMA numbers
- not on file
- Product code
- EBI
- Firm FEI
- 1315551
- Firm city
- Albany
- 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