Z-1905-2016 Class II Terminated
FDA device recall Z-1905-2016 was initiated by Exactech, Inc. on Apr 12, 2016 and is designated Class II. Reason for recall: Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval. The recall status is terminated (terminated Jul 24, 2019). Affected quantity: 9 devices.
Recall Details
- Product Type
- Devices
- Report Date
- Jun 8, 2016
- Initiation Date
- Apr 12, 2016
- Termination Date
- Jul 24, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9 devices.
Product Description
Novation Press-Fit Splined, Standard Offset, HA Coated, 12/14 Taper, Size 11, Femoral Stem; Catalog Number 160-30-11; For use in primary total hip arthroplasty.
Reason for Recall
Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
Distribution Pattern
Distributed in FL, NJ, NY, OH, OK, RI, TN, VA and HI.
Code Information
Product Codes: LPH, MEH, LWJ, JDI; Catalog Number 160-30-11, Serial Numbers: 4273184, 4273185, 4273187, 4273188, 4273189, 4273190, 4273191, 4273192 and 4273186, Exp. 2/8/2021.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1905-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026