Recall Z-1788-2014— Kerr Corporation
Class II · Terminated
Class II FDA medical device recall by Kerr Corporation, initiated 2014-05-29, terminated 2014-10-27. It names one FDA 510(k) clearance: K951663. 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: 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..
- Recalling firm
- Kerr Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-05-29
- Terminated
- 2014-10-27
- Firm location
- Romulus, MI, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.