||January 26, 2009
||Terminated on January 20, 2010
|Recall Event ID
Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer - Product Code JWH
These devices are modular components of a total knee system. These modular stems are intended for use with femoral and tibial components in primary or revision total knee arthroplasty.
||5565-S-015 TRI PRESS-FIT STEM 15MM X 100MM M3M07B,
5565-S-016 TRI PRESS-FIT STEM 16MM X 100MM M3M01B,
5565-S-016 TRI PRESS-FIT STEM 16MM X 100MM M3M01E,
5565-S-017 TRI PRESS-FIT STEM 17MM X 100MM M3M03A,
5566-S-012 TRI PRESS-FIT STEM 12X150MM M3L11F,
5566-S-013 TRI PRESS-FIT STEM 13X150MM M3L12B,
5566-S-018 TRI PRESS-FIT STEM 18X150MM M3L17D
|Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430
|For Additional Information Contact
||Karen Ariemma, RAC
|Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.
|PRODUCTION CONTROLS: Packaging Process Control
||Recall notification letters were sent via Federal Express on November 21, 2008 to Stryker Branches/Agencies, Hospital Risk Management, Chief of Orthopaedics and Surgeon. The letters explained the problem and indicated that there are no risk factors. Contact Stryker Orthopaedics for additional information at 1-201-831-5718.
|Quantity in Commerce
||322 total units - all types
||Nationwide. OUS: Australia, Canada, Japan, Argentina, Brazil, Germany, Spain, Columbia, Guatemala and Sweden.
|Total Product Life Cycle
TPLC Device Report
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K)s with Product Code = JWH and Original Applicant = HOWMEDICA OSTEONICS CORP
510(K)s with Product Code = JWH and Original Applicant = HOWMEDICA OSTEONICS CORP.
510(K)s with Product Code = JWH and Original Applicant = IND DIAGNOSTIC INC.
510(K)s with Product Code = JWH and Original Applicant = OSTEONICS CORP.
510(K)s with Product Code = JWH and Original Applicant = STRYKER ORTHOPAEDICS