Recall Z-1283-2015 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Triathlon Distal Capture Assembly Catalog No: 6541-1-723 The Triathlon Distal Capture Assembly is used when a surgeon elects to use a capture for the distal femoral resection or proximal tibial resection in a Triathlon primary total knee arthroplasty (TKA).
| Date | Mar 16, 2015 (initiated Feb 12, 2015) |
| Status | Terminated |
| Reason | Potential for weld disassociation of the cross pin, which could lead to loose or disassociated trigger mechanism on the Distal Capture Assembly. |
| Root cause | Device Design |
| Action | On March 20, 2015, Stryker sent Urgent Medical Device Recall Notifications/Urgent Medical Device Recall Notification Acknowledgement Forms dated March 19, 2015 to all affected customers. The letter identified the product, the related issue and the action to be taken by the customers. Customers were asked to return the attached acknowledgement form confirmed they received and reviewed the notification. Customers with questions were instructed to call 201-831-6365. Stryker sent an Urgent Medical Device Correction letter dated February 11, 2015, to all affected customers. The letter identifi |
| Quantity | 2030 units |
| Distribution | Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Canada, Hong Kong, Netherlands, Sweden, Switzerland, Spain, France, Italy, UK, India, Australia, Korea, Panama, Polan, Ireland, Kuala Lumpar, New Zealand and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123486 | TRIATHLON TRITANIUM TIBIAL BASEPLATE Stryker, May 3, 2013 |