Z-0292-2019 Class II Terminated
FDA device recall Z-0292-2019 was initiated by CMP Industries, Llc on September 12, 2018 and is designated Class II. Reason for recall: Foreign material in product The recall status is terminated (terminated May 19, 2020). Affected quantity: 400 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 7, 2018
- Initiation Date
- September 12, 2018
- Termination Date
- May 19, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 400 units
Product Description
IMPAK Elastic Acrylic Resin Liquid Heat Cure Type 1, Class I, 1 Quart (946ml) REF:3306. Product Usage - Impak Elastic Acrylic Resin Liquid, Used for Dental Splints and Dental Nightguards
Reason for Recall
Foreign material in product
Distribution Pattern
Worldwide distribution, US Nationwide in the states of CA, FL, IL, MI, NY, OK, OR, PA, TX, WA and countries of Canada and Spain.
Code Information
Lot Number: 85623 , 85827