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 Recall Z-1865-2008 · Posted 2008-09-16
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeKTT
Date Initiated2005-01-25
Date Terminated2008-09-24
Product Quantity20 units
Reason for Recall
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.
Firm Action
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.
Root Cause
Process control
Distribution Pattern
To Stryker branches and hospitals nationwide.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
K955306OMEGA+ COMPRESSION SCREW SYSTEMHowmedica Corp. · 1996-04-10K930156MEGA PLUS SUPER LAG SCREWPfizer Hospital Products Group, Inc. · 1994-02-22K922295OMEGA PLUS COMPRESS HIP SCREW SYSTEM, MODIFICATIONHowmedica Corp. · 1992-09-08K872223MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEMHowmedica Corp. · 1987-06-26K850886COMPRESSION HIP SCREW SYSTEMPfizer, Inc. · 1985-04-19
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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