Foundation Knee System Instrumentation, Tibial Broach Assembly. Used in conjunction with the Tibial Sizing Template and Tibial Broach Guide to prepare the resected tibial plateau for acceptance of a keeled tibial baseplate stem.
FDA Recall Z-2734-2011 · Posted 2011-07-05
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Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeHTQ
Date Initiated2011-04-21
Date Terminated2012-04-06
Product Quantity15 units
Reason for Recall
Strike plate may dislodge from the broach stem handle during impaction of the device.
Firm Action
Encore Medical, Lp (d.b.a. DJO Global) sent out a "Urgent Field Safety Notice" dated April 20, 2011 to all affected customers. The firm also e-mailed the consignees as well.
The letter described the product, affected lots, reason for recall and provided recommendations including; asking customers contact firm for a replacement, provided a "Field Safety Response Form" to fill out and return. The firm also e-mailed the consignees as well.
For additional information please contact the Director of Commercial Logistics at (512) 834-6330 or the International Customer Service at 512 834-6275.
Root Cause
Process control
Distribution Pattern
Louisiana and Arkansas and the countries of Germany, Italy, United Kingdom and Japan.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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