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Continuum Acetabular System Trabecular Metal Shell with… recallZ-0094-2015 · Zimmer, Inc. · initiated Oct 1, 2014

Class II Terminated All recalls posted in October 2014

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 affected products are missing polar boss threads.

FDA root cause category: Equipment maintenance

What the company is doing

Zimmer sent an "URGENT MEDICAL DEVICE RECALL- LOT SPECIFIC" notifications dated October 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Your Responsibilities 1. Review the notification and ensure affected personnel are aware of the contents. 2. If you find any product from the affected lot , quarantine the product and notify your Zimmer sales representative. 3. Your Zimmer sales representative will remove the recalled product from your facility. 4. For patients that previously had this product implanted, it is recommended that you continue your normal post operative follow up routine. 5. If after reviewing this notification you have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 5:00pm EST.

Recall details

Recall number
Z-0094-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 1, 2014
Posted by the FDA
Oct 20, 2014
Recalling firm
Zimmer, Inc.
Quantity
19
Product code
JDI
FDA submissions
K091508
Distribution
Worldwide Distribution: US (nationwide) in the states of : IA, CA, NC, AL, WA, FL, TN, MA, AZ, TX, UT, and NV; and Internationally to Japan.

Product description

Continuum Acetabular System Trabecular Metal Shell with Multi Holes, Porous 68mm, Prosthesis, Hip, Semi-Constrained, Metal/Polymer

Code information (models, lots, serial numbers)

Part Number: 00-8757-068-02; Lot Number: 62207029

Other devices under the same FDA submission

40 devices cleared under K091508 — 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

How recalls are matched to devices · Editorial policy · Report an error on this page