Device product
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.
Z-1462-2018
Product summary
- Event
- Event 79600
- Status
- Terminated
- Classification
- Class II
- Quantity
- 77 total products
- Official record key
device-enforcement:Z-1462-2018
Official wording
Reason: Customers may receive the incorrect size implant from what is labeled on the box.
Code information: Catalog #5545-A-301, lot code ER9WA1A, ER9WA1D, ER9WA1E Catalog #5546-A-601, lot code ER9MA5A
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
Derived failure modes
-
Unknown
Customers may receive the incorrect size implant from what is labeled on the box.