Stryker Howmedica Osteonics Corp. Stryker Trial Head xx-Long (+16mm) Neck Length 26mm Diameter Sterile, Forged Vitallium Alloy; Product Number 6264-8-526; Howmedica Osteonics Corp. Styrker Ireland; Carrigwohill Inustrial Estate; Carrigtwohill county Cork, Ireland. Made in Ireland. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Stryker Trial Head xx-Long (+16mm) Neck Length 26mm Diameter Sterile, Forged Vitallium Alloy; Product Number 6264-8-526; Howmedica Osteonics Corp. Styrker Ireland; Carrigwohill Inustrial Estate; Carrigtwohill county Cork, Ireland. Made in Ireland.
Brand
Stryker Howmedica Osteonics Corp.
Lot Codes / Batch Numbers
26mm +16mm TRIAL HEAD-- Product Number: 6264-8-526 All Lot codes
Products Sold
26mm +16mm TRIAL HEAD-- Product Number: 6264-8-526 All Lot codes
Stryker Howmedica Osteonics Corp. is recalling Stryker Trial Head xx-Long (+16mm) Neck Length 26mm Diameter Sterile, Forged Vitallium Alloy; Produc due to Fracture of Stem Neck - The firm recently performed laboratory testing indicates that there may be a potential increased risk of stem neck fractures w. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Fracture of Stem Neck - The firm recently performed laboratory testing indicates that there may be a potential increased risk of stem neck fractures when a V40 +16mm offset femoral head is mated with certain Accolade TMZF femoral stems in patients classified as overweight or obese.
Recommended Action
Per FDA guidance
Stryker Orthopaedics sent an Urgent Product Recall notification letters on November 9, 2007, by Federal Express with return receipt. The letter informed users of potential increased risk of stem neck fracture, when a V40 + 16mm offset femoral head is mated with certain Accolade TMZF femoral stems in patients classified as overweight or obese. The firm has asked that inventory be examined, removed and held in quarantine. A Stryker representative will contact the medical facilities to retrieve the product. If a representative has not contacted the facility to date, it is suggested that they contact Stryker at (201) 831-5972.
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