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Terminated

Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System.

FDA Recall Z-0042-04 · Posted 2003-10-15

Recalling FirmOrtho Development Corporation
Recall StatusTerminated
Product CodeJWH
Date Initiated2003-09-15
Date Terminated2003-12-11
Product Quantity27

Reason for Recall

The guide pin which rotationally constrains the tibial punch within the punch guide, may fall out.

Firm Action

The firm has telephoned all distributors regarding the recall. An advisory note and product return request letters were sent to all distributors on 9/15/03.

Root Cause

Other

Distribution Pattern

Units were sent to distributors in AZ, CA, FL, MO, OK and TX. Units were also distributed to firm's parent company in Japan.

Official Source

View FDA Recall →

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

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