Z-1462-2018 Class II Terminated
FDA device recall Z-1462-2018 was initiated by Howmedica Osteonics Corp. on Jan 30, 2018 and is designated Class II. Reason for recall: Customers may receive the incorrect size implant from what is labeled on the box. The recall status is terminated (terminated May 7, 2020). Affected quantity: 77 total products.
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- Jan 30, 2018
- Termination Date
- May 7, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 77 total products
Product Description
Triathlon Revision Knee Catalog #5545-A-301 and Catalog #5546-A-601 The knee system devices are sterile, single-use devices intended for us in revision total knee arthroplasty to alleviate pain and restore function.
Reason for Recall
Customers may receive the incorrect size implant from what is labeled on the box.
Distribution Pattern
USA (nationwide) Distribution to the states of : AL, AZ, CA, FL, GA, KS, MA, MD, MI, NC, NJ, NY, OH, PA, SC, TN, TX, VA, and WA
Code Information
Catalog #5545-A-301, lot code ER9WA1A, ER9WA1D, ER9WA1E Catalog #5546-A-601, lot code ER9MA5A
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1462-2018
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026