Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision surgery. A distal centralizer is provided for optimal placement within the femoral canal. The system is used with Type 1 taper modular heads and compatible acetabular shells/liners and screws to provide a total hip replacement system.
Enforcement
- Recall Number
- Z-0823-2015
- Event ID
- 69932
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Biomet, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 24, 2014
- Initiation Date
- December 2, 2014
- Classification Date
- December 17, 2014
- Termination Date
- October 27, 2015
- Address
- 56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States
Description
Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision surgery. A distal centralizer is provided for optimal placement within the femoral canal. The system is used with Type 1 taper modular heads and compatible acetabular shells/liners and screws to provide a total hip replacement system.
After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and shipment: Sirius Polish Cemented Stem 348 Catalog Number: 51-199333, Lot Number Identification: 024320 and Sirius Polish Cemented Stem 38C, Catalog Number: 51-199335, Lot Number Identification: 141680, 180920.
Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920
Foreign Distribution in China and Australia only.
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