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Short Barrel Sideplate, Omega + 140 degrees, 4 slots recallZ-1865-2008 · Stryker Howmedica Osteonics Corp. · initiated Jan 25, 2005

Terminated All recalls posted in September 2008

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Stryker Howmedica Osteonics Corp. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

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.

FDA root cause category: Process control

What the company is doing

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.

Recall details

Recall number
Z-1865-2008
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Jan 25, 2005
Posted by the FDA
Sep 16, 2008
Recalling firm
Stryker Howmedica Osteonics Corp.
Quantity
20 units
Product code
KTT
FDA submissions
K850886, K872223, K922295, K930156, K955306
Distribution
To Stryker branches and hospitals nationwide.

Product description

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.

Code information (models, lots, serial numbers)

Catalog Number: 3362-0-404 Lot code: E00985

Other devices under the same FDA submission

6 devices cleared under K850886, K872223, K922295, K930156, K955306 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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