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Nextgen Complete Knee Solution Replacement Jaw for Use with… recallZ-2092-2012 · Zimmer Inc. · initiated Apr 30, 2012

Class II Terminated All recalls posted in July 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Zimmer Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. The spring clip may fracture or fall off of the instrument during use, and a device fragment may be left in the surgical site. The risk of disassembly or fracture occurs when the instrument is typicall

FDA root cause category: Component design/selection

What the company is doing

Zimmer sent an Urgent Medical Device Recall letter dated April 30, 2012, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Requests for alternative instruments should be requested by calling (574) 372-4470. Fax Back Inventory Return Certification Form is to be sent back to Zimmer at (574) 372-4265. All recalled instruments available at the distributor are to be returned to Zimmer Product Service Department, 1777 West Center Street, Warsaw, IN 46580. The Distributor notice included instructions to notify surgeons immediately of the recall and requested a list of hospitals and surgeons receiving the device be sent back to Zimmer via E-mail. Zimmer is continuing distribution of the replacement jaw ( 005901-026-40) until alternative tools are available. The distributors are asked to identify and deliver preferred alternative instruments to affected accounts. Beginning May 7, 2012 Urgent Recall notices are being sent to hospitals and surgeons identified with instructions to acknowledge the recall communication. For questions regarding this recall call 574-372-4807.

Recall details

Recall number
Z-2092-2012
Recall class
Class II
Status
Terminated
Initiated by the company
Apr 30, 2012
Posted by the FDA
Jul 27, 2012
Recalling firm
Zimmer Inc.
Quantity
65 units
Product code
MBH
FDA submissions
K031061
Distribution
Worldwide Distribution - USA (nationwide) and the countries of Singapore, China, Hong Kong, Canada, Australia, Japan, Europe, Germany, India, and Finland.

Product description

Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.

Code information (models, lots, serial numbers)

Part 00-5901-026-40 Lot 62011774, 61870067, and 61813699 Initially the 00-5901-026-40 replacement jaws will remain available for order until all of the alternative instruments are in place, however they will also be required to be returned. The final lot numbers and manufacture dates will be provided in a subsequent status update.

Other devices under the same FDA submission

6 devices cleared under K031061 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 61764).

Sources and updates

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