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Class 2 Device Recall IMPAK ELASTIC ACRYLIC RESIN LIQUID |
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| Date Initiated by Firm |
September 12, 2018 |
| Create Date |
October 30, 2018 |
| Recall Status1 |
Terminated 3 on May 19, 2020 |
| Recall Number |
Z-0292-2019 |
| Recall Event ID |
81206 |
| Product Classification |
Resin, denture, relining, repairing, rebasing - Product Code EBI
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| Product |
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 |
| Code Information |
Lot Number: 85623 , 85827 |
Recalling Firm/
Manufacturer |
CMP Industries, Llc
413 N Pearl St
Albany NY 12207-1311
|
| For Additional Information Contact |
SAME
518-434-3147
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Manufacturer Reason
for Recall |
Foreign material in product
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FDA Determined
Cause 2 |
Material/Component Contamination |
| Action |
Nobilium, A Division of CMP Industries LLC notified customer by phone and certified mail on 9/12/18 advising users of the problem and to return product..
Distributors requested to notify the user level (dental laboratory who processed this material. Questions, call 518-434-3147, extension 144, M-F 8-4:30pm (Eastern). |
| Quantity in Commerce |
400 units |
| Distribution |
Worldwide distribution, US Nationwide in the states of CA, FL, IL, MI, NY, OK, OR, PA, TX, WA and countries of Canada and Spain. |
| Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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