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Terminated

EPIK KNEE SYSTEM Angled Insert Impactor LM/RL; Catalog #801-03-051 Rev. A; non-sterile; knee prosthesis instrument. Distributed by Encore Medical, L.P., Austin, TX 78758.

FDA Recall Z-0009-2008 · Posted 2007-10-10

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeHRY
Date Initiated2007-08-09
Date Terminated2008-03-10
Product Quantity5 units.

Reason for Recall

Angled Insert Impactor may scratch Tibial Insert on the articulating surface, causing increased wear at the damaged site.

Firm Action

Firm notified consignees regarding recall via letter on 08/09/07. Consignees informed that Encore customer service representatives would be contacting them to exchange recalled units with replacements.

Root Cause

Device Design

Distribution Pattern

Products distributed to direct accounts in CA, FL and MD.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K022437UNI KNEEEncore Medical L.P. · 2002-08-23K020741UNICONDYLAR KNEEEncore Orthopedics, Inc. · 2002-06-04

Official Source

View FDA Recall →

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

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