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[Recalled] CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty. — Zimmer Inc | FDA 2012-09-13

recall fda device united-states

This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.

Recall details

ProductCPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
Brand / manufacturerZimmer, Inc.
Categorydevice
Issuing authorityFDA_DEVICE
ReferenceZ-0062-2013
Country of noticeUnited States
Risk levelClass II
Hazard typerecall
Notice date13 September 2012
EAN / barcode61947699

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10 ) because devices were packaged in incorrect cartons and distributed internationally and domestically. Zimmer received five complaints of this packaging issue.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from Zimmer, Inc.

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.

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