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Terminated

PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.

FDA Recall Z-1610-2014 · Posted 2014-05-13

Recalling FirmOrtho Development Corporation
Recall StatusTerminated
Product CodeJWH
Date Initiated2014-04-01
Date Terminated2014-07-14
Product Quantity5

Reason for Recall

A femoral component containing pegs was found in a box for the pegless version.

Firm Action

Ortho notified customers via email and phone calls on April 1, 2014. Customers were asked to return product in inventory.

Root Cause

Process control

Distribution Pattern

US Nationwide Distribution in the states of NV, and AZ.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K994370ORTHO DEVELOPMENT BALANCED KNEE SYSTEMOrtho Development Corp. · 2000-03-24

Official Source

View FDA Recall →

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

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