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Zimmer femoral stem, revision taper, 15 mm diameter, 185 mm… recallZ-1615-2009 · Zimmer Inc. · initiated May 15, 2009

Terminated All recalls posted in July 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 threads on the screw are incomplete/non-functional.

FDA root cause category: Process control

What the company is doing

Zimmer, Inc. began Consignee notification of the affected device via telephone on May 15, 2009. A certified "Urgent: Device Recall" notification dated May 21, 2009 was sent to all consignees instructing them of the affected device, to stop use of and return it with a Return Certification form. The Return Verification form should also be faxed to Zimmer, Inc. at 1-574-372-4265. For shipping assistance, questions or other concerns, contact Zimmer, Inc. at 1-800-613-6131.

Recall details

Recall number
Z-1615-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 15, 2009
Posted by the FDA
Jul 6, 2009
Recalling firm
Zimmer Inc.
Quantity
10
Product code
LWJ
FDA submissions
K992667
Distribution
Worldwide Distribution -- US states of IA, NE and CA and countries of Canada, Switzerland, United Kingdom, Hungary, Netherlands and Slovakia.

Product description

Zimmer femoral stem, revision taper, 15 mm diameter, 185 mm stem length, w/compression nut, sterile, Zimmer, Warsaw, IN; Model Number: 9982-15-18. Cement-less total hip arthroplasty in patients whose bone stock is of poor quality or inadequate for other reconstruction techniques. Devices placed in femoral canal. A variety of stem and body components are provided to achieve fixation and restore joint kinematics.

Code information (models, lots, serial numbers)

Lot Number: 60698102.

Other devices under the same FDA submission

7 devices cleared under K992667 — 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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