Z-0062-2013 Class II Terminated
FDA device recall Z-0062-2013 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: 59 both lots.
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
- 59 both lots
Product Description
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.
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
Item 00-8114-001-10, lots 61947699 and 61952551
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0062-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026