Z-1865-2008

Short Barrel Sideplate, Omega + 140 degrees, 4 slots; The Omega Plus Compression Screw system consists of a...

Name: Z-1865-2008 Short Barrel Sideplate, Omega + 140 degrees, 4 slots; The Omega Plus Compression Screw system consists of a...
Creator: Stryker Howmedica Osteonics Corp.
Published: 2005-01-25
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2005-01-25 / Terminated / root cause: manufacturing process

FDA source

Stryker Howmedica Osteonics Corp. began a recall of 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... on 2005-01-25. The reason FDA records is "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1865-2008
Status: Terminated
Initiated: 2005-01-25
Posted: 2008-09-16
Terminated: 2008-09-24
Recalling firm: Howmedica Osteonics Corp
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.
Product code: KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
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.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 20 units
Distribution: To Stryker branches and hospitals nationwide.
Product codes and lots: Catalog Number: 3362-0-404 Lot code: E00985

Product code KTT

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)