||January 26, 2009
||Terminated on January 20, 2010
|Recall Event ID
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented - Product Code LZO
||Primary Secur-fit Plus Max Hip Stem
These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthroplasty.
||6054-0812S PRIMARY SECUR-FIT PLUS MAX #8/12 72MMME,
6054-0812S PRIMARY SECUR-FIT PLUS MAX #8/12 WA5MLE,
6054-0915S PRIMARY SECUR-FIT PLUS MAX #9/15 11AMME,
6054-1014S PRIMARY SECUR-FIT PLUS MAX #10/14 AKKMME,
6054-1014S PRIMARY SECUR-FIT PLUS MAX #10/14 AKXMME,
6054-1014S PRIMARY SECUR-FIT PLUS MAX #10/14 DHKMME and
6054-1218S PRIMARY SECUR-FIT PLUS MAX #12/18 EP2MME
|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 = LZO and Original Applicant = HOWMEDICA OSTEONICS CORP
510(K)s with Product Code = LZO and Original Applicant = HOWMEDICA OSTEONICS CORP.
510(K)s with Product Code = LZO and Original Applicant = IND DIAGNOSTIC INC.
510(K)s with Product Code = LZO and Original Applicant = OSTEONICS CORP.
510(K)s with Product Code = LZO and Original Applicant = STRYKER ORTHOPAEDICS