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Terminated

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

FDA Recall Z-1234-2009 · Posted 2009-04-28

Recalling FirmDentsply Worldwide Headqrt
Recall StatusTerminated
Product CodeELR
Date Initiated2009-03-20
Date Terminated2010-02-12
Product Quantity1588 posts

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

Worldwide distribution: USA, Canada, Germany, France, Holland, Switzerland, The Netherlands, Italy, Kuwait, Poland, Argentina, Greece, Russia, Czech Republic, Belgium, Turkey, Hungary, India, and Colombia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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