Tytin Regular Set — Class II medical device recall Z-1788-2014
Terminated recall by Kerr Corporation, reported 2014-06-25, distributed nationwide. Kerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948, Lot Number 3-1294), becaus
| Recall number | Z-1788-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Kerr Corporation, Romulus, MI, United States |
| Recall initiated | 2014-05-29 |
| Classified | 2014-06-13 |
| Reported by FDA | 2014-06-25 |
| Terminated | 2014-10-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BE, CA, CZ, DE, ES, FR, GB, IT, MX, PT, SA |
| Quantity | 2,030 units |
| Lot numbers | 3-1294 |
| Model numbers | 29948 |
| Expiration dates | 2016-10-20 |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1788-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.