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U.S. Department of Health and Human Services

Class 2 Device Recall CYTCOK TITANIUM POST SYSTEM

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 Class 2 Device Recall CYTCOK TITANIUM POST SYSTEMsee related information
Date Initiated by FirmMarch 20, 2009
Date PostedApril 28, 2009
Recall Status1 Terminated 3 on February 12, 2010
Recall NumberZ-1234-2009
Recall Event ID 51469
Product Classification dental implant components - Product Code ELR
ProductDentsply, 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
Code Information 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 
FEI Number 3004884150
Recalling Firm/
Manufacturer		 Dentsply Worldwide Headqrt
221 W Philadelphia St Ste 6
York PA 17401-2992
For Additional Information ContactCharles K. Pigott
717-849-4574
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionDentsply 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 Commerce1588 posts
DistributionWorldwide distribution: USA, Canada, Germany, France, Holland, Switzerland, The Netherlands, Italy, Kuwait, Poland, Argentina, Greece, Russia, Czech Republic, Belgium, Turkey, Hungary, India, and Colombia.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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