Medical Device Recall: Z-0017-04

FDA Recalls dataset · Firm: Plus Endoprothetik AG Erlenstrasse 4b Rotkreuz Switzerland · Status: Terminated

Recall Action Class: N/A Date Initiated: 2003-04-17 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0017-04.

Recall Res Number

Z-0017-04

Recalling Firm / Manufacturer

Plus Endoprothetik AG Erlenstrasse 4b Rotkreuz Switzerland

FEI Number

3002807898

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2003-04-17

Date Posted

2003-10-15

Date Terminated

2003-12-03

Product Code

N/A

Event Number

26326

Product Quantity

Product Description TC-PLUS Solution Tibial Component-- Symmetric

Reason for Recall Labeling/packaging mix-up.

Action Details Firm notified implanting surgeons by letter and telephone on May 16, 2003 and on June 2, 2003. One physician was contacted on August 26, 2003. The firm communicated the need to follow-up with the patients . Recall is complete.

Distribution Pattern TX, CA, VA, ID, NY, UT, FL

Code Information / Serial Numbers Lot 0211.13.4553

Public Record Disclaimer

This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.