TempSpan Dual-Cure Temporary Crown and Bridge Material, PART NUMBER N69AD, The intended use of this device is to make a
FDA device recall Z-0482-2010 · posted 2009-12-03 · Terminated
Recall details
- Recalling firm
- Jeneric/Pentron
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- EBG
- Quantity affected
- 58 units
- Distribution
- Nationwide
- Date initiated
- 2009-10-22
- Date posted
- 2009-12-03
- Date terminated
- 2012-07-19
- Location
- Wallingford, CT
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| FLEX SPAN TEMPORARY CROWN & BRIDGE MATERIAL (K021457) | Pentron Corp. | 2002-08-01 |