FDA Device Recall Z-0018-06: Plus Orthopedics USA

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0018-06.

Recall Res Number

Z-0018-06

Recalling Firm / Manufacturer

Plus Orthopedics USA

FEI Number

3001237832

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2005-08-03

Date Posted

2005-10-07

Date Terminated

2006-06-16

Product Code

JWH

Event Number

32882

Product Quantity

Product Description TC-PLUS Tibial Insert UC 6; 13mm, Model 25438

Reason for Recall Did not meet specifications.

Action Details Recall was by scripted telephone conversations to two consignees. Products were returned under RMA.

Distribution Pattern Arizona, California, Idaho, New York, Texas, and Virginia

Code Information / Serial Numbers Lot code: 0501.13.0199, 0303.13.1616

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Medical Device Recall: Z-0018-06

Recall Parameters & Description

Related Establishments / Registrations

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