SCORPIO-FLEX 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.
FDA Recall Z-1684-2011 · Posted 2011-03-16
Advertisement
Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLXH
Date Initiated2010-07-13
Date Terminated2017-09-29
Product Quantity159, 095 units, all types
Reason for Recall
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).
Firm 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 201-831-6069.
For any questions customers were to call 201-972-2100 or 201-831-5028.
Root Cause
Other
Distribution Pattern
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, South Africa, United Kingdom. and Canada.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement