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Zimmer VerSys Hip System Femoral Head, 12/14 taper, 28 mm… recallZ-0198-2010 · Zimmer Inc. · initiated Aug 3, 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

Manufacturing material may be present on the surface of the implant.

FDA root cause category: Manufacturing material removal

What the company is doing

An Urgent: Device Recall letter, dated 8/3/2009, was issued to consignees. The letter identified the affected product, stated the reason for the recall, the clinical implications (risks to health), and actions to be taken. Customers are to locate any unused devices and quarantine them immediately, carry out a physical count of affected product and record the data on the Return Certification Form included with the letter, and fax a copy of the completed form back to Zimmer, Inc. at 574-372-4265. Customers are to return the recalled product along with the completed Inventory Return Certification Form. A "Dear Surgeon" letter will be issued to any hospitals where the devices have been implanted.

Recall details

Recall number
Z-0198-2010
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Aug 3, 2009
Posted by the FDA
Nov 13, 2009
Recalling firm
Zimmer Inc.
Quantity
104
Product code
LPH
FDA submissions
K953337
Distribution
Worldwide Distribution -- USA, Brazil, Canada, and Switzerland.

Product description

Zimmer VerSys Hip System Femoral Head, 12/14 taper, 28 mm dia., neck length +0 mm, sterile, Zimmer, Warsaw, IN; REF 8018-28-02. Intended for mating femoral stems equipped with tapered necks.

Code information (models, lots, serial numbers)

Lot 60378581.

Other devices under the same FDA submission

22 devices cleared under K953337 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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