Z-0061-2013 Class II Terminated
FDA device recall Z-0061-2013 was initiated by Zimmer, Inc. on Sep 13, 2012 and is designated Class II. Reason for recall: 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 )… The recall status is terminated (terminated Jan 15, 2014). Affected quantity: 20.
Recall Details
- Product Type
- Devices
- Report Date
- Oct 24, 2012
- Initiation Date
- Sep 13, 2012
- Termination Date
- Jan 15, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20
Product Description
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 for Recall
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.
Distribution Pattern
Worldwide Distribution-USA (nationwide) including the states of Indiana and Oklahoma and the countries of Australia, Thailand, Malaysia, Germany, India, Bulgaria, Egypt, UK, Russian FED, Slovak, and Brazil.
Code Information
Lot 62017554
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0061-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026