CLASS II Device recall · Reported 27 Jun 2012 · FDA Enforcement Report
Peak SE Primer Kits (4 syringes per kit) recalled by Ultradent Products
Ultradent Products is recalling Peak SE Primer Kits (4 syringes per kit). The recall was initiated on 24 May 2012 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1822-2012
- FDA event ID
- 62120
- Recalling firm
- Ultradent Products, South Jordan, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 May 2012
- FDA classified
- 18 Jun 2012
- Reported
- 27 Jun 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Device type
- Syringes & Needles
Timeline
| 24 May 2012 | Recall initiated by company | |
| 18 Jun 2012 | Classified by FDA | +25 days |
| 27 Jun 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Product as listed by the FDA
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.
Where it was distributed
Worldwide Distribution.
Questions about this recall
Why was it recalled?
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.
Which lots are affected?
Lot number: B6Z4K.
Where was it sold?
Worldwide Distribution.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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