Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The Biomet's Sirius
FDA device recall Z-0823-2015 · posted 2014-12-17 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- 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 348 Catalog Number: 51-199333, Lot Number Identification: 024320 and Sirius Polish Cemented Stem 38C, Catalog Number: 51-199335, Lot Number Identification: 141680, 180920.
- Action taken
- Sent notices to customers dated 12/2/2014 notifying them of the recall: 5 were implanted, 3 were shipped to subsidiary for testing, and 2 are in Biomet control. Public Contact for the recall is: Audrey Daenzer, Field Action Specialist, Regulatory Compliance audrey.daenzer@biomet.com, can be contacted from Monday through Friday 8 AM to 5 PM, 574-372-1570.
- Root cause
- Mixed-up of materials/components
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 8
- Distribution
- Foreign Distribution in China and Australia only.
- Date initiated
- 2014-12-02
- Date posted
- 2014-12-17
- Date terminated
- 2015-10-27
- Location
- Warsaw, IN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SIRIUS FEMORAL STEM (K130610) | Biomet, Inc. | 2013-08-30 |