—#70997

Product

Short Barrel Sideplate, Omega + 140 degrees, 4 slots; The Omega Plus Compression Screw system consists of a series of lag screws, proximal hip side plates, supracondylar side plates, and compression screw designed to be used in the temporary stabilization of fractures of the proximal femur (intracapsular or intertrochanteric) and/or distal third of the femur (supracondylar area. These components are now made available in sterile packaging.

FDA product code: KTT — Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K850886, K872223, K922295, K930156, K955306
Affected lot / code info: Catalog Number: 3362-0-404 Lot code: E00985

Why it was recalled

Stryker Orthopaedics became aware that the packaging labeled as catalog number 3362-0-040; lot code E00985, 140 x 4 slot may contain a 5 hole slot.

Root cause (FDA determination)

Process control

Action the firm took

Stryker branches and agencies were notified by letter on January 25, 2005. Letters to branches were notified of the packaging error and asked that all inventory location be examined to identify product. Product was to be returned to Stryker. If the product was further distributed, letters were provided to be sent to hospital OR Supervisors. A reconciliation form was also included and asked to be completed and returned. For information on this recall contact Rita Intorella at 201-831-5825.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2002

Distribution

Distribution pattern: To Stryker branches and hospitals nationwide.

Timeline

Recall initiated: 2005-01-25
Posted by FDA: 2008-09-16
Terminated: 2008-09-24
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #70997. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.