Recall Z-1654-2023 · MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Howmedica Osteonics Corp.
TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
| Date | May 30, 2023 (initiated Apr 13, 2023) |
| Status | Open, Classified |
| Reason | Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa |
| Root cause | Under Investigation by firm |
| Action | Stryker issued Urgent Medical Device Recall letter n 4/13/23 via UPS 2-Day Air Product Field Action #: 3268231. Letter states reason for recall and action to take: Our records indicate that you may have received the affected product(s). It is Stryker's responsibility as the manufacturer to ensure that customers who may have received these affected products also receive this important communication. We therefore request that you read this notice carefully and complete the following actions. 1. Please inform users of this Urgent Medical Device Recall and forward this notice to all individuals w |
| Quantity | 24 units in total |
| Distribution | US Nationwide - Worldwide Distribution: CT, FL, IN, KY, MT, NJ, OR, PA, SC Foreign: China, Japan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K172634 | Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components Howmedica Osteonics Corp. A.K.A. Stryker Orthopaedics, Nov 16, 2017 |