Stryker LFIT COCR V40 Femoral Head; xx-Long (+16mm) Neck Length 28mm Diameter Sterile, Forged Vitallium Alloy; Product N

FDA device recall Z-0966-2008 · posted 2008-02-07 · Terminated

Recall details

Recalling firm

Stryker Howmedica Osteonics Corp.

Reason for recall

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.

Action taken

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.

Root cause

Other

Status

Terminated

Product code

JDI

Quantity affected

5,599 total units

Distribution

Nationwide Distribution

Date initiated

2007-11-02

Date posted

2008-02-07

Date terminated

2010-08-30

Location

Mahwah, NJ