Recall record at a glance
| Official record | Z-1824-2020 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical |
| Report date | May 6, 2020 |
| Recall initiation date | Feb 25, 2020 |
| Quantity | 111 kits |
| Location | Orange, CA, United States |
Official product description
Nexus Universal with OptiBond Universal, Universal Adhesive Resin Cement, Trial Kit, Ref # 36990 - Product Usage: The intended use of this device is to be used for the cementation of indirect restorations including veneers, inlays, onlays, bridges, posts, and the cementation of crown restorations to implant abutments.
Why the product was recalled
An issue within production process used to package trial kits let to the inclusion of the incorrect bonding agent for the kit. Use of the incorrect bonding agent may lead to increased risk of bond failures.
Distribution information
Worldwide distribution - US Nationwide distribution in the states of NV, TN, NY, WA, WI, GA, PA, TX, IN, FL, IL, IA, MD, CA, LA, , MI, AZ, NC, KY, SC and the country of Netherlands.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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