FDA Device recall Z-0061-2013
CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05
- FDA Device
- Class II
- terminated
- Published 2012-10-24
On 2012-10-24 the FDA classified a Class II recall of CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05 by Zimmer, citing 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,(i….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0061-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-09-13 |
| Published | 2012-10-24 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
CPT Hip System Femoral Stem Petite, Item No. 00-8011-000-05. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.
Reason
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.
Identifiers
| code_info | Lot 62017554 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0061-2013%22
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