Medical Device Recall: Z-0042-04

FDA Recalls dataset · Firm: Ortho Development Corporation · Status: Terminated

Recall Action Class: N/A Date Initiated: 2003-09-15 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0042-04.

Recall Res Number
Z-0042-04
Recalling Firm / Manufacturer
Ortho Development Corporation
FEI Number
3017298928
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2003-09-15
Date Posted
2003-10-15
Date Terminated
2003-12-11
Product Code
JWH
Event Number
27300
Product Quantity
27
Product Description Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System.
Reason for Recall The guide pin which rotationally constrains the tibial punch within the punch guide, may fall out.
Action Details 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.
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.
Code Information / Serial Numbers Part # 252-0300, Lot # W007919.

Related Establishments / Registrations

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