Z-1234-2009

Dentsply, MAILLEFER, CYTCO-K TITANIUM POST SYSTEM, dental implant components, Model numbers (SKU)...

Name: Z-1234-2009 Dentsply, MAILLEFER, CYTCO-K TITANIUM POST SYSTEM, dental implant components, Model numbers (SKU)...
Creator: Dentsply Worldwide Headqrt
Published: 2009-03-20
License: https://open.fda.gov/license/

Dentsply Sirona Inc / initiated 2009-03-20 / Terminated / root cause: manufacturing process

FDA source

Dentsply Worldwide Headqrt began a recall of Dentsply, MAILLEFER, CYTCO-K TITANIUM POST SYSTEM, dental implant components, Model numbers (SKU): C106KL0050A20 (12 posts) and C117K00000020 (4 posts), Swiss... on 2009-03-20. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1234-2009
Status: Terminated
Initiated: 2009-03-20
Posted: 2009-04-28
Terminated: 2010-02-12
Recalling firm: Dentsply Sirona Inc
Product: 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
Product code: ELR Post, Root Canal
Reason for recall: 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 tag: manufacturing process
FDA 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 also sent out identical recall letters to those they distributed the product on 03/25/09.
Quantity in commerce: 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.
Product codes and lots: C106KL0050A20 (12 posts), Packing Lot Numbers: 2045470, 2457580, 2725900, 2918670, 3032820, 3174500, 3328470, 3626480, and 3779590 C117K00000020 (4 posts), Packing Lot Numbers: 2660790, 3076090, 3231740, and 3797230

Product code ELR

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)