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.
This recall has been terminated (originally issued September 16, 2008).
- Recall Initiated
- January 25, 2005
- Posted
- September 16, 2008
- Terminated
- September 24, 2008
- Recall Number
- Z-1865-2008
- Quantity
- 20 units
- Firm Location
- Mahwah, NJ
- Official Source
- View on FDA website ↗
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.
Distribution
To Stryker branches and hospitals nationwide.
Lot / Code Info
Catalog Number: 3362-0-404 Lot code: E00985
Root Cause
Process control
Action Taken
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.