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Zimmer Kinectivo Technology Modular Neck, BB, 12/14 neck… recallZ-1617-2009 · Zimmer Inc. · initiated May 29, 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 corner tab of the inner compartment lid was not folded under before the outer lid was sealed, resulting in lack of assurance of sterility.

FDA root cause category: Packaging process control

What the company is doing

Zimmer, Inc. issued "Urgent: Device Recall" notices dated May 29, 2009 informing Consignees of the affected devices. Users were instructed to locate and return affected product and complete and return an Inventory Return Certification form via fax to the firm at 1-547-372-4265. For further questions, contact Zimmer, Inc. at 1-800-613-6131.

Recall details

Recall number
Z-1617-2009
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
May 29, 2009
Posted by the FDA
Jul 27, 2009
Recalling firm
Zimmer Inc.
Quantity
147 of both products.
Product code
LPH
FDA submissions
K063251
Distribution
Worldwide Distribution -- United States, Brazil, Canada, Chile, Czech Republic, Finland, France, Germany, Italy, Korea, Lebanon, Switzerland and United Kingdom.

Product description

Zimmer Kinectivo Technology Modular Neck, BB, 12/14 neck taper, sterile, Zimmer, Warsaw, IN; Catalog Number: 00-7848-022-01. Orthopedic implant used in total hip arthroplasty.

Code information (models, lots, serial numbers)

Lot Number: 60917793.

Other devices under the same FDA submission

16 devices cleared under K063251 — 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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