Recall Z-1234-2009 ยท ELR Post, Root Canal
Dentsply Worldwide Headqrt
Dentsply, MAILLEFER, CYTCO-K TITANIUM POST SYSTEM, dental implant components, Model numbers (SKU): C106KL0050A20 (12 posts) and C117K00000020 (4 posts), Swiss Made, Manufactured for DENTSPLY Maillefer, Johnson City, TN 37604
| Date | Apr 28, 2009 (initiated Mar 20, 2009) |
| Status | Terminated |
| Reason | The product is manufactured with a left-hand thread instead of a right hand thread. This error could cause tooth breakage if the posts were removed without knowing that the threads were reversed. |
| Root cause | Process control |
| Action | Dentsply notified their distributors and dentists of the recall by email sent on 03/20/2009 by Urgent Recall Notice letter explaining the problem and requesting return of the product from their inventory and from their consignees. The letter requests faxback response (enclosed with the recall notification) within five (5) working days. The letter included a response page to ensure the receipt of the notice. A second follow up letter will be sent to all that do not respond to the first letter. The firm identified another distributor within the company, DENTSPLY Tulsa Specialty Products, who |
| Quantity | 1588 posts |
| Distribution | Worldwide distribution: USA, Canada, Germany, France, Holland, Switzerland, The Netherlands, Italy, Kuwait, Poland, Argentina, Greece, Russia, Czech Republic, Belgium, Turkey, Hungary, India, and Colombia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.