Recall Z-0482-2010 ยท EBG Crown And Bridge, Temporary, Resin
Jeneric/Pentron
TempSpan Dual-Cure Temporary Crown and Bridge Material, PART NUMBER N69AD, The intended use of this device is to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.
| Date | Dec 3, 2009 (initiated Oct 22, 2009) |
| Status | Terminated |
| Reason | Pentron Clinical Technologies LLC received two (2) complaints alleging that the TempSpan Dual-Cure Temporary Crown and Bridge Material was not setting. Investigation of product in inventory was conducted and it was confirmed that some of the bottles had been mispackaged with an incorrect catalyst. |
| Root cause | Employee error |
| Action | The recall customer notification was initiated on October 22, 2009 with the firm forwarding an urgent medical device letter with recall return form via USPS first class mail to the affected consignees. The letter informed the consignees of the reason for recall and instructed them to return any used or unused product of the affected lot. The firm provided an 800 number for the consignees to call to arrange for product return and replacement. |
| Quantity | 58 units |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021457 | FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL Pentron Corp., Aug 1, 2002 |