Recall Z-1259-2024 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Howmedica Osteonics Corp.
X3 TRIATHLON CS INSERT NO 3 10 MM
| Date | Mar 6, 2024 (initiated Feb 6, 2024) |
| Status | Open, Classified |
| Reason | Potential packaging breaches of inner blister and outer sterile blister. |
| Root cause | Packaging |
| Action | URGENT MEDICAL DEVICE RECALL notifications dated 02/06/2024 were distributed to consignees by mail. Consignees were asked to forward the provided recall notice to all individuals within the organization who need to be made aware and organizations who have consigned product, immediately check all stock and operating room storage for affected devices, quarantine and discontinue use of recalled devices, complete and return the provided Business Reply Form by email to strykerortho4004@sedgwick.com or by fax to 855-800-1093. Consignees are to contact their local sales office or Stryker Sales Repres |
| Quantity | 132 units (US); 26 units (OUS) |
| Distribution | Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile, Colombia, Korea, & Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K173849 | Triathlon Total Knee System Stryker Orthopaedics, Feb 2, 2018 |