Stryker Howmedica Osteonics Corp. Citation TMZF HA Hip Stem - LT. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Citation TMZF HA Hip Stem - LT. Hip stems are single use devices intended for cementless fixation. The products are intended for use in primary reconstruction of the proximal femur or revision of a previous total hip arthroplasty.
Brand
Stryker Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
6265-5103 CITATION TMZF SIZE 3 LEFT 24640201 and 6265-5103 CITATION TMZF SIZE 3 LEFT 25109201.
Products Sold
6265-5103 CITATION TMZF SIZE 3 LEFT 24640201 and 6265-5103 CITATION TMZF SIZE 3 LEFT 25109201.
Stryker Howmedica Osteonics Corp. is recalling Citation TMZF HA Hip Stem - LT. Hip stems are single use devices intended for cementless fixation. due to Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystal. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Product deviation : Specific lots of sprayed HA hip stems did not meet Stryker's Internal Material Specification for tensile bond strength and crystallinity.
Recommended Action
Per FDA guidance
An "Urgent Product Recall" letter was sent via Federal Express on January 6, 2009 with return receipt to Stryker Branches/Agencies, Hospital Risk Management, Hospital Chief of Orthopaedics and Surgeons. The letter described the affected product, issue, potential hazards and risks. Stryker Branches and Hospital Risk Management were asked to examine their inventory for affected product. Stryker Representatives were instructed to contact customers to reconcile and return recalled product to Stryker Orthopaedics. All letters include a response form to be completed and returned indicating that they have been informed of the recall and the amount of product on hand, if any. Direct questions about the recall to Stryker Orthopaedics at 1-201-831-5718.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026