Z-1901-2016 Class II Terminated
FDA device recall Z-1901-2016 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: 2 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
- 2 devices.
Product Description
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 56mm, O.D. (Acetabular Cup), Catalog Number 140-01-56; 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 Code: MRA, Catalog Number 140-01-56, Serial Numbers: 4268399 and 4268400, Exp. 2/6/2021.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1901-2016
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026