Recall Z-0362-2016 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Duracon Flat Tibial Wedge Cemented use only Sterile. Tibial Wedge is a component of Total Stabilizer Knee which consists of femoral component, tibial insert, modular offset adaptor, femoral/tibial stem extenders and tibial wedges. Tibial wedges are intended to be used with the Universal tibial baseplate to augment bone loss on the surface of the tibia.
| Date | Dec 2, 2015 (initiated Sep 21, 2015) |
| Status | Terminated |
| Reason | Stryker Orthopaedics has received two customer complaints regarding Duracon Tibial Wedge implants puncturing the packaging's Tyvek lid(s). |
| Root cause | Under Investigation by firm |
| Action | On September 18, 2015, Stryker notified their Branches/Agencies of their action via email. The Branches/Agencies were instructed to quarantine affected devices. Urgent Medical Device Recall Notification Letters/Urgent Medical Device Recall Notification Acknowledgement Forms dated September 21, 2015 were sent to Branches/Agencies via UPS on 9/21/2015. Urgent Medical Device Recall Notification Letters/Urgent Medical Device Recall Notification Acknowledgement Forms dated September 21, 2015 were sent to Hospital Risk Managers via UPS on 9/23/2015. The notification instructed consignees on h |
| Quantity | 2,577 units |
| Distribution | Distributed US (nationwide) and the countries of Australia, Canada, Germany, Hong Kong, Italy, Japan, Malaysia, New Zealand, Netherlands, Poland, Romania, Spain, Sweden and Switzerland. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973164 | HOWMEDICA TOTAL STABILIZER KNEE COMPONENTS Howmedica Corp., Nov 20, 1997 |