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Zimmer Gender Solutions Natural-Knee Flex System, Prolong… recallZ-0247-2010 · Zimmer Inc. · initiated Oct 8, 2009

Terminated All recalls posted in November 2009

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 surgeon may have difficulty inserting the polyethylene into the tibial baseplate, which may result in intraoperative damage to the device.

FDA root cause category: Other

What the company is doing

An "Urgent: Field Correction" dated October 8, 2009 was issued to Consignees. The notification letter described the affected product, issue, health risks and actions for customers to take. The letter notified consignees of a changed to the surgical technique, to include the use of a new peripheral rib impactor tool. Notifications of this field notification were sent to all affected direct accounts of Zimmer, Inc. Contact your Zimmer Sales Representative if you have any questions regarding this action. For shipping assistance, questions or assistance in notifying your accounts about the field correction please contact Zimmer, Inc. at 1-800-613-6131.

Recall details

Recall number
Z-0247-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Oct 8, 2009
Posted by the FDA
Nov 13, 2009
Recalling firm
Zimmer Inc.
Quantity
26,404 of all products
Product code
JWH
FDA submissions
K070214
Distribution
Worldwide Distribution -- United States, Austria, Belgium, France, Germany, Japan, Spain and Switzerland.

Product description

Zimmer Gender Solutions Natural-Knee Flex System, Prolong Articular Surface, ultracongruent, Size 00,0, right, 16 MM height, for use with baseplate size 00 or 0, sterile, Zimmer, Warsaw, IN; REF 00-5428-020-16. The device is a semiconstrained total knee prosthesis components indicated for uncemented or cemented use in skeletally mature individuals.

Code information (models, lots, serial numbers)

Lots 60971797, 60971801, 60981877, 60987846, 60988249, 60993031, 60993032, 60993033, 60993034, 61001568, 61012281, 61017824, 61023701, 61036417, 61045114, 61051497, 61065068, 61069433, 61078778, 61085899, 61091218, 61091219, 61101490 and 61114204.

Other devices under the same FDA submission

14 devices cleared under K070214 — 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 53399).

Sources and updates

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