Recall Z-0249-2016 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics, MIS MODULAR DISTAL CAPTURE TRIATHLON MIS INSTRUMENTS, REF 6541-5-723, Lot AdminECR19205, Non-Sterile, The Triathlon MIS Distal Capture is used when a surgeon elects to use a capture for the distal femoral resection in a Triathlon primary MIS TKA. Once the Triathlon MIS distal Resection Guide (cat. no. 6541-5-721/722, for left or right preparation, respectively) has been secur
| Date | Nov 9, 2015 (initiated Sep 29, 2015) |
| Status | Terminated |
| Reason | Stryker is recalling various lots of the Trithion MIS Modular Distal Capture because complaints were received that specific lots of this product may disassociate during use. |
| Root cause | Nonconforming Material/Component |
| Action | Stryker notified their Branches/Agencies of this recall by email on September 29, 2015 and notifiction letters and product accountability forms were sent via UPS (with return receipt) on September 29, 2015 to branches and on September 30, 2015 to hospitals. Stericycle wil be handling the returns. Customers with questions were instructed to call 201-831-5826. For questions regarding this recall call 201-831-5272. |
| Quantity | 3,444 units |
| Distribution | Nationwide Distribution including AZ, DE, ID, IL, KS, LA, MI, NH, NM, NJ, NY, OH, PA,TX, VA, VT, WA and WI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K123486 | TRIATHLON TRITANIUM TIBIAL BASEPLATE Stryker, May 3, 2013 |