Recall Z-1146-2012 ยท ELW Material, Impression
Sybron Dental Specialties
Correct VPS Vinyl Polysilocane Impression Material, Product Number Q01B. The intended use of this device is as a dental impression material.
| Date | Mar 2, 2012 (initiated Nov 4, 2010) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Packaging process control |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K914178 | CORRECTED-V.P.S. Jeneric/Pentron, Inc., Apr 28, 1992 |