Recall record at a glance
| Official record | Z-1788-2014 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Kerr Corporation |
| Report date | Jun 25, 2014 |
| Recall initiation date | May 29, 2014 |
| Quantity | 2,030 units |
| Location | Romulus, MI, United States |
Official product description
Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this device is to be used as a dental restorative material in the treatment of dental caries.
Why the product was recalled
Kerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948, Lot Number 3-1294), because it may set faster than specified in the Directions for Use.
Distribution information
Worldwide Distribution-USA (nationwide) and the countries of Canada, Mexico, Australia, Belgium, Czech Republic, Germany, Spain, France, Great Britain, French Guiana, Italy, Portugal, and Saudi Arabia.
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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