Recall Z-1865-2008 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Stryker Howmedica Osteonics Corp.
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
| Date | Sep 16, 2008 (initiated Jan 25, 2005) |
| Status | Terminated |
| Reason | 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 | 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 | 20 units |
| Distribution | To Stryker branches and hospitals nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K850886 | COMPRESSION HIP SCREW SYSTEM Pfizer, Inc., Apr 19, 1985 |
| K872223 | MODIFIED OMEGA COMPRESSION HIP SCREW SYSTEM Howmedica Corp., Jun 26, 1987 |
| K922295 | OMEGA PLUS COMPRESS HIP SCREW SYSTEM, MODIFICATION Howmedica Corp., Sep 8, 1992 |
| K930156 | MEGA PLUS SUPER LAG SCREW Pfizer Hospital Products Group, Inc., Feb 22, 1994 |
| K955306 | OMEGA+ COMPRESSION SCREW SYSTEM Howmedica Corp., Apr 10, 1996 |