Recall Z-1681-2011 ยท JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
SCORPIO CR TIBIAL TRIAL, non sterile, made in the USA Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430. The Tibial trial are utilized during surgery to assess the overall component fit, ligament stability, and joint range of motion prior to final implantation of the insert to the tray.
| Date | Mar 16, 2011 (initiated Jul 13, 2010) |
| Status | Terminated |
| Reason | Stryker Orthopaedics became aware that there is the potential for the Scorpio T72 tibial Insert Trials to be oversized by a maximum of .024" (0.6mm). |
| Root cause | Other |
| Action | Stryker Howmedica Osteonics Corp.sent Urgent Product Correction letters Correction letters dated July 23, 2010, via Federal Express to all affected customers. were sent to all Stryker Branches on July 23, 2010 via Federal Express. Asia Pacific, Canada, Europe, Middle East, Africa, Japan and Latin America sites were sent letters on July 26, 2010 by Federal Express. The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the attached Product Correction Acknowledgement Form by fax as soon as possible to 201 |
| Quantity | 159,095 units, all types. |
| Distribution | Worldwide Distribution - USA including OH, TX, MS, and CO and the countries of Australia, Hong Kong, Taiwan, India, Korea, Japan, Chile, Brazil, Columbia, Venezuela, , Panama, Santo Domingo, Mexico, Argentina, Costa Rica, Guatemala, Peru,Sweden, Germany, Netherlands, France, Spain, Italy, Romania, S |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.