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Terminated

FOUNDATION KNEE SYSTEM Tibial Fixed Impactor, Revision A and B; Catalog #801-01-449; distributed by Encore Medical, L.P., Austin, TX 78758. The Tibial Fixed Impactor, a part of the FOUNDATION KNEE SYSTEM, is a manual orthopedic surgical instrument intended to lock onto the baseplate to impact the implant.

FDA Recall Z-2466-2008 · Posted 2008-09-29

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeJWH
Date Initiated2008-08-04
Date Terminated2009-08-03
Product Quantity68 units.

Reason for Recall

Complaints received regarding the fracture of the Nitronic 60 screw on the Tibial Fixed Impactor during surgery.

Firm Action

Recall notification sent via letter starting on 08/04/07. Consignees asked to quarantine and return affected devices. Contact Encore Medical, Lp at 1-512-834-6330 for assistance.

Root Cause

Device Design

Distribution Pattern

FL and TX and OUS: Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K970031FOUNDATION KNEE SYSTEM TIBIAL COMPONENTEncore Orthopedics, Inc. · 1997-04-02K941306FOUNDATION KNEE AUGMENTATION BLOCKSEncore Orthopedics, Inc. · 1995-02-08K923277FOUNDATION KNEE SYSTEMEncore Orthopedics, Inc. · 1993-02-09

Official Source

View FDA Recall →

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

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