FDA Medical Device Recalls (openFDA)
Stryker Howmedica Osteonics Corp.: Stryker Trial Head xx-Long (+16mm) Neck Length 32mm Diameter Sterile, Forged Vitallium Alloy; 6264-8-532; Howmedica Osteonics Corp. Styrker Ireland; Carrigtwohill county Cork, Ireland. Made in Ireland.
- Recall number
- Z-0970-2008
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Product
- Stryker Trial Head xx-Long (+16mm) Neck Length 32mm Diameter Sterile, Forged Vitallium Alloy; 6264-8-532; Howmedica Osteonics Corp. Styrker Ireland; Carrigtwohill county Cork, Ireland. Made in Ireland.
- Status
- Terminated
- Initiated
- 2007-11-02
- Posted
- 2008-02-07
- Terminated
- 2010-08-30
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 5,599 total units
- Distribution
- Nationwide Distribution
- Lot, serial or model codes
- 32MM/+16MM TRIAL HEAD-- Product Number: 6264-8-532 All Lot Codes
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JDI
- Firm FEI
- 3003070421
- Firm city
- Mahwah
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28