—#67211

Product

Stryker Advanced Cement Mixer (ACM) Bowl and Base without 180 Gram Cement Cartridge for use with Stryker High Vacuum Cement Injection System, sterile; REF 306-554, Stryker Instruments, Kalamazoo, MI 49001.

FDA product code: JDZ — Mixer, Cement, For Clinical Use
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: Lot Numbers: 05167CG2, 05192012, 05223012 and 06335012.

Why it was recalled

Sterility may be compromised, as the packaging may have channels in the packaging seal.

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

Stryker notified consignees via Medical Device Recall Notification letter dated 1/10/08 to quarantine the product and to return it.

Recalling firm

Firm: Stryker Instruments Div. of Stryker Corporation
Address: 4100 E. Milham Ave., Portage, Michigan 49002-9704

Distribution

Distribution pattern: Nationwide Distribution - Illinois, Michigan, New York, Ohio and Wyoming.

Timeline

Recall initiated: 2008-01-10
Posted by FDA: 2008-05-01
Terminated: 2008-07-31
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #67211. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.