Stryker Howmedica Osteonics Corp. Accolade HFx 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. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Accolade HFx 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.
Brand
Stryker Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
6077-0230 Accolade HFx Size #2 8XAMLE, 6077-0230 Accolade HFx Size #2 8XEMLE, 6077-0335 Accolade HFx Size #3 8PAMME, 6077-0435 Accolade HFx Size #4 8PEMME, 6077-0435 Accolade HFx Size #4 PJLMLE and 6077-0435 Accolade HFx Size #4 R27MLE
Products Sold
6077-0230 Accolade HFx Size #2 8XAMLE, 6077-0230 Accolade HFx Size #2 8XEMLE, 6077-0335 Accolade HFx Size #3 8PAMME, 6077-0435 Accolade HFx Size #4 8PEMME, 6077-0435 Accolade HFx Size #4 PJLMLE and 6077-0435 Accolade HFx Size #4 R27MLE
Stryker Howmedica Osteonics Corp. is recalling Accolade HFx These devices are modular components of a total hip system. These femoral stems are i due to Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Stryker Orthopaedics became aware of a visual defect in certain blister packages of certain devices.
Recommended Action
Per FDA guidance
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.
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