Recall Z-2836-2016 ยท KIF Resin, Root Canal Filling
Ormco/Sybronendo
Sealapex Xpress, Part No. 33639 The brand name of the device is Sealapex Xpress, a root canal filling resin. Sealapex Xpress is intended to be used during endodontic therapy to fill the root canal of a tooth.
| Date | Sep 16, 2016 (initiated Aug 31, 2016) |
| Status | Terminated |
| Reason | SybronEndo is recalling the Sealapex Xpress because it was labeled with an incorrect expiration date of 2017-11 while the syringe was labeled with the correct expiration date of 2016-11. |
| Root cause | Employee error |
| Action | The firm, Kerr, sent an "Urgent: Medical Device Recall" letter dated 8/31/16 to its customers. The letter describes the product, problem and actions to be taken. The customer were instructed to contact SybronEndo Customer Care at (800) 537-7123 to receive a RMA number if they have any of the affected product; and to complete and email back the enclosed acknowledgement form to Sealapex.Response@kerrdental.com , even if they do not have any of the affected product. If you have any questions, call 714-516-7802 or email to: mark.dzendzel@syndrondental.com. |
| Quantity | 179 units |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: Canada, Australia, Mexico, Belgium, Denmark, Germany, Great Britain, and Sweden. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K010940 | SEALAPEX 4 Sybron Dental Specialties, Inc., Jun 20, 2001 |