Z-2086-2014 Class II Terminated
FDA device recall Z-2086-2014 was initiated by Exactech, Inc. on Mar 7, 2014 and is designated Class II. Reason for recall: The femoral stem is lacking specified plasma coating. The recall status is terminated (terminated Aug 4, 2014). Affected quantity: 10.
Recall Details
- Product Type
- Devices
- Report Date
- Jul 30, 2014
- Initiation Date
- Mar 7, 2014
- Termination Date
- Aug 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product Description
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be implanted to replace a hip joint with our without bone cement.
Reason for Recall
The femoral stem is lacking specified plasma coating.
Distribution Pattern
Worldwide Distribution including Spain, Greece and Japan
Code Information
Serial Numbers: 2910243, 2910244, 2910245, 2910246, 2910247, 2910248, 2910249, 2910250, 2910251, and 2910252
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-2086-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026