Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm length Cancellous Bone Screws (Cat no 2029-5540-1) are cleared for use in Total Hip Arthroplasty (THA), when implanting Stryker's Hemispherical Cluster Hole Acetabular Shell Systems and Total Knee Arthroplasty (TKA) when implanting Stryker's Series 7000 Standard Tibial Tray systems. The use of bone screws, during both THA and TKA are intended as supplemental fixation.
Enforcement
- Recall Number
- Z-0483-2014
- Event ID
- 66908
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Stryker Howmedica Osteonics Corp.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 18, 2013
- Initiation Date
- October 1, 2013
- Classification Date
- December 11, 2013
- Termination Date
- July 15, 2015
- Address
- 325 Corporate Dr, Mahwah, NJ, 07430-2002, United States
Description
Stryker Orthopaedics Cancellous Bone Screw Howmedica Osteonics Corp. Stryker France Both the 6.4 mm diameter, 25mm length, Cancellous Bone Screws (Cat no 2030-6525-1) and the 5.5mm diameter, 40 mm length Cancellous Bone Screws (Cat no 2029-5540-1) are cleared for use in Total Hip Arthroplasty (THA), when implanting Stryker's Hemispherical Cluster Hole Acetabular Shell Systems and Total Knee Arthroplasty (TKA) when implanting Stryker's Series 7000 Standard Tibial Tray systems. The use of bone screws, during both THA and TKA are intended as supplemental fixation.
Stryker received a report from the field indicating that a 5.5 mm Cancellous Bone Screw 40 mm was identified in packaging associated with a 6.5 mm Cancellous Bone Screw 25 mm.
1) 6.5 mm Cancellous Bone Screw 25mm Catalog No: 2030-6525-1 Lot code MMLNLA 2) 5.5 Cancellous Bone Screw 40 mm Catalog No: 2029-5540-1 Lot Code MMLMJ1
Nationwide Distribution
Catalog Number 2030-6525-1- 4 units; Catalog No: 2029-5540-1-7 units