Z-0201-2016 Class II Terminated
FDA device recall Z-0201-2016 was initiated by Exactech, Inc. on Sep 23, 2015 and is designated Class II. Reason for recall: Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating. The recall status is terminated (terminated Mar 1, 2017). Affected quantity: 8.
Recall Details
- Product Type
- Devices
- Report Date
- Nov 11, 2015
- Initiation Date
- Sep 23, 2015
- Termination Date
- Mar 1, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8
Product Description
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems, Intended for press-fit fixation
Reason for Recall
Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
Distribution Pattern
US Distribution to states of: AZ, CO, FL, and MD.
Code Information
Catalog Number 164-13-09 Serial Numbers: 4076815, 4076816, 4076817, 4076818, 4076819, 4076820, 4076821, and 4076822.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0201-2016
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026