Enforcement Report - Week of June 27, 2012
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Product Detail
| Product Description | Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. The product is contained within prefilled, labeled syringes in a transparent plastic container identified with an aqua, red, orange, blue and black label with black and blue print writing. Product code: 5135, 872.3200 KLE, liquid and powder mixture is a syringe-in-a-syringe delivery system. The product is used for most bonding needs in restorative dentistry. Bonds chemical cure luting and chemical cure composites, namely PermaFlo DC. Peak SE does not require a separate etching step for quality adhesion. Peak SE is also conducive for bonding to: Dentin and enamel, porcelain, metal and composite. |
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| Recall Number | Z-1822-2012 |
| Classification | Class II |
| Code Info | Lot number: B6Z4K. |
| Product Distributed Qty | 172 kits (4 syringes per kit) |
| Reason For Recall | Ultradent is recalling lot B6Z4K of Peak SE Primer as a result of a field complaint, dated May 10, 2012, stating that a syringe of Peak SE Primer was mislabeled as Peak LC Bond Resin. These products are used by Dental professionals for bonding needs in restorative dental procedures. |
Event Detail
| Event Id | 62120 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Ultradent Products, Inc. |
| City | South Jordan |
| State | UT | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-05-24 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | Worldwide Distribution. |
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