[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
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | 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. |
|---|---|
| Brand / manufacturer | Zimmer, Inc. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-0062-2013 |
| Country of notice | United States |
| Risk level | Class II |
| Hazard type | recall |
| Notice date | 13 September 2012 |
| EAN / barcode | 61947699 |
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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