Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is as a dental
FDA device recall Z-1146-2012 · posted 2012-03-02 · Terminated
Recall details
- Recalling firm
- Sybron Dental Specialties
- Reason for recall
- Pentron Clinical is voluntarily recalling the following lot of mislabeled Correct VPS Medium Body Tubes. It was discovered that the individual tubes inside the Correct VPS Medium Body Tube boxes are missing the lot/expiration date sticker.
- Action taken
- Pentron Clinical sent "Urgent Medical Device Recall" letters dated November 17, 2010 to consignees explaining the above mentioned public reason for recalls and asking them to determine if they have any of the affected products in their in stock. Product that is returned will be replaced at no charge. They also asked that they complete and fax back an enclosed recall return form. Questions can be directed to Customer Service at (800) 551-0283.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- ELW
- Quantity affected
- 176 units
- Distribution
- Worldwide Distribution, USA including the states of FL, NY, WA, CA, IL, MA, NC, NJ, AZ, FL, KY, CT, PA, IN, NJ, PA, TN, NV, TX and the countries of Canada and Pakistan.
- Date initiated
- 2010-11-04
- Date posted
- 2012-03-02
- Date terminated
- 2012-03-14
- Location
- Orange, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CORRECTED-V.P.S. (K914178) | Jeneric/Pentron, Inc. | 1992-04-28 |