FDAClass IIDecember 31, 2014

NexGen Complete Knee Solution Monoblock Tibial recall

NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer…

Why was NexGen Complete Knee Solution Monoblock Tibial recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
NexGen Complete Knee Solution Monoblock Tibial Provisional / Drill Guide Tibial Size 5 Femoral Size Green / CH Zimmer U.K. Ltd., SN3 4FP, UK Zimmer…
Recalling firm
Zimmer Trabecular Metal Technology, Inc.
Quantity
8 units
Distribution
Worldwide Distribution - US Distribution and the countries of Australia and Denmark.
Recall date
December 31, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls