Foundation Tibia Baseplate, Catalog number 324-01-108. The tibial is modular in design, such that plastic inserts of various thicknesses and intramedullary stem are attached to the metal baseplate intraoperatively.
FDA Recall Z-0622-2010 · Posted 2010-01-13
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Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeJWH
Date Initiated2009-12-03
Date Terminated2010-05-05
Product Quantity17
Reason for Recall
Product does not meet specifications for a size 8 Right Foundation Tibia Baseplate.
Firm Action
Firm notified consignees by an Urgent Field Safety Notice dated 12/3/2009. The letter identified the product, stated the problem, and the risk associated with the problem. Customers are to immediately return the affected product and notify all of their customers if product was further distributed. Customers are to complete and return the enclosed response form. Questions should be directed to David Harris, Manager of Customer Service at 512-834-6330 or Valerie Moulton, International Customer Service at 512-834-6275.
Root Cause
Mixed-up of materials/components
Distribution Pattern
Worldwide Distribution -- USA, including states of GA, OK, FL, CA, and SD, and countries of Germany and Turkey.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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