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CPT Femoral Stem (CPT 12/14 STEM SIZE 0 COCR recallZ-0069-2014 · Zimmer, Inc. · initiated Aug 30, 2013

Class II Terminated All recalls posted in October 2013

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 low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.

FDA root cause category: Package design/selection

What the company is doing

August 30, 2013 Urgent Recall Notices were sent to Distributors, hospital risk managers and surgeons identifying the issue and directing consignees to make all affected personnel aware of the contents of the notification. The notice identified the products involved, the issue, possible adverse events associated with the issue and recommended that implants found with LDPE bag adhesion not use the product and return it to Zimmer sales representatives. Questions or concerns should be addressed to Zimmer customer call center at 1-877-946-2761 between the hours of 8 a.m. and 5 p.m. EST.

Recall details

Recall number
Z-0069-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 30, 2013
Posted by the FDA
Oct 25, 2013
Recalling firm
Zimmer, Inc.
Quantity
24561
Product code
JDI
FDA submissions
K960658
Distribution
Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.

Product description

CPT Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SIZE 1 COCR; CPT 12/14 SIZE 1 COCR EXT CPT 12/14 STEM SIZE 2 COCR; CPT 12/14 SIZE 2 COCR EXT; CPT 12/14 SIZE 2 COCR 180MM; CPT 12/14 SIZE2 COCR XEXT; CPT 12/14 STEM SIZE 3 COCR; CPT 12/14 SIZE 3 COCR EXT; CPT 12/14 SZ 3 COCR 180MM EXT; CPT 12/14 SIZE 3 COCR XEXT; CPT 12/14 STEM SIZE 4 COCR; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SZ 4 COCR 230MM EXT; CPT 12/14 SZ 4 COCR 260MM EXT; CPT 12/14 SIZE 4 COCR XEXT; CPT 12/14 STEM SIZE 5 COCR; CPT 12/14 SIZE 5 COCR EXT; CPT 12/14 SIZE 5 COCR XEXT; CPT 12/14 STEM 2-180 VALGUSNCK; CPT 12/14 STEM 3-180 VALGUSNCK; CPT 12/14 STEM X-SML COCR; and CPT 12/14 STEM SML COCR). Indicated for cemented use in patients suffering from severe hip pain.

Code information (models, lots, serial numbers)

Part Number Range: 00-8114-000/050-00/30

Other devices under the same FDA submission

23 devices cleared under K960658 — 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 65799).

Sources and updates

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