Z-1512-2018 Class II Terminated
FDA device recall Z-1512-2018 was initiated by Howmedica Osteonics Corp. on Jan 12, 2018 and is designated Class II. Reason for recall: Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box. The recall status is terminated (terminated May 7, 2020). Affected quantity: 6 units of catalog 5521-B-400.
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- Jan 12, 2018
- Termination Date
- May 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6 units of catalog 5521-B-400
Product Description
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
Reason for Recall
Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box.
Distribution Pattern
Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition.
Code Information
Catalog 5521-B-300, lot code ATV7IA Catalog 5521-B-400, lot code ATY40A
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1512-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026