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NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Si...

FDA Recall #Z-0851-2015 — Class II — December 2, 2014

Recall #Z-0851-2015 Date: December 2, 2014 Classification: Class II Status: Terminated

Product Description

NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer Trabecular Metal Technology, Inc 10 Pomeroy Road, Parsippany, NJ 07054 USA

Reason for Recall

During cleaning, two separate units of the NexGen Tibial Base plates did not fit with the Tibial Base Plate handle.

Recalling Firm

Zimmer Trabecular Metal Technology, Inc. — Parsippany, NJ

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

8 units

Distribution

Worldwide Distribution - US Distribution and the countries of Australia and Denmark.

Code Information

Part number 00-5887-045-00 Lot number 62592928

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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