Z-0822-2015 Class II Terminated
FDA device recall Z-0822-2015 was initiated by Biomet, Inc. on Dec 2, 2014 and is designated Class II. Reason for recall: 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 34B… The recall status is terminated (terminated Oct 27, 2015). Affected quantity: 9.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 24, 2014
- Initiation Date
- Dec 2, 2014
- Termination Date
- Oct 27, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9
Product Description
Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented Device Common Name: Sirius Femoral Stem 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.
Reason for Recall
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 34B Catalog Number: 51-199333, Lot Number Identification: 024320 and Sirius Polish Cemented Stem 38C, Catalog Number: 51-199335, Lot Number Identification: 141680, 180920.
Distribution Pattern
Foreign Distribution in China and Australia only.
Code Information
Sirius Polish Cemented Stem 348 Catalog Number: 51-199333 Lot Number Identification: 024320
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0822-2015
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026