Peak SE Primer Kits (4 syringes per kit) manufactured by Ultradent Products, Inc, South Jordan, UT, Self Etch Primer. Th
FDA device recall Z-1822-2012 · posted 2012-06-18 · Terminated
Recall details
- Recalling firm
- Ultradent Products, Inc.
- 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.
- Action taken
- Ultradent Products Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 5, 2012 to all affected customers. The letter identifies the product, problem, and actions to be taken by the customers. The letter instructs customers to discard any affected product from their 5135 kit. Customers were asked to complete and return a Recall Return Response form to the firm by fax at 801-553-4609.
- Root cause
- Labeling mix-ups
- Status
- Terminated
- Product code
- KLE
- Quantity affected
- 172 kits (4 syringes per kit)
- Distribution
- Worldwide Distribution.
- Date initiated
- 2012-05-24
- Date posted
- 2012-06-18
- Date terminated
- 2012-08-15
- Location
- South Jordan, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PEAK SE, MODEL 5135 (K063558) | Ultradent Products, Inc. | 2006-12-14 |