Z-0069-2014 Class II Terminated
FDA device recall Z-0069-2014 was initiated by Zimmer, Inc. on Aug 30, 2013 and is designated Class II. Reason for recall: The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices. The recall status is terminated (terminated Sep 25, 2014). Affected quantity: 24561.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 6, 2013
- Initiation Date
- Aug 30, 2013
- Termination Date
- Sep 25, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24561
Product Description
CPT¿ Femoral Stem (CPT 12/14 STEM SIZE 0 COCR; CPT 12/14 SIZE 0 COCR EXT; CPT 12/14 STEM SIZE 1 COCR; CPT 12/14 SIZE 1 COCR EXT CPT 12/14 STEM SIZE 2 COCR; CPT 12/14 SIZE 2 COCR EXT; CPT 12/14 SIZE 2 COCR 180MM; CPT 12/14 SIZE2 COCR XEXT; CPT 12/14 STEM SIZE 3 COCR; CPT 12/14 SIZE 3 COCR EXT; CPT 12/14 SZ 3 COCR 180MM EXT; CPT 12/14 SIZE 3 COCR XEXT; CPT 12/14 STEM SIZE 4 COCR; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SIZE 4 COCR EXT; CPT 12/14 SZ 4 COCR 230MM EXT; CPT 12/14 SZ 4 COCR 260MM EXT; CPT 12/14 SIZE 4 COCR XEXT; CPT 12/14 STEM SIZE 5 COCR; CPT 12/14 SIZE 5 COCR EXT; CPT 12/14 SIZE 5 COCR XEXT; CPT 12/14 STEM 2-180 VALGUSNCK; CPT 12/14 STEM 3-180 VALGUSNCK; CPT 12/14 STEM X-SML COCR; and CPT 12/14 STEM SML COCR). Indicated for cemented use in patients suffering from severe hip pain.
Reason for Recall
The low density polyethylene (LDPE) bag used to package implants adheres to the highly polished surface of the devices.
Distribution Pattern
Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Bolivia, Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic, Ecuador, El Salvador, Germany, Guatemala, Honduras, Hong Kong, India, Israel, Jamaica, Japan, Korea, Malaysia, Mexico, New Zealand, Nicaragua, Panama, Peru, Singapore, Taiwan, Thailand, and Venezula.
Code Information
Part Number Range: 00-8114-000/050-00/30
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0069-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026