Z-0823-2015Class II

Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The...

Name: Z-0823-2015 Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The...
Creator: Biomet, Inc.
Published: 2014-12-02
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2014-12-02 / Terminated / root cause: packaging

FDA source

Biomet, Inc. began a recall of 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... on 2014-12-02. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0823-2015
Classification: Class II
Status: Terminated
Initiated: 2014-12-02
Posted: 2014-12-17
Terminated: 2015-10-27
Recalling firm: Zimmer GmbH
Product: 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.
Product code: JDI Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
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.
Root cause tag: packaging
FDA root cause: Mixed-up of materials/components
Action: 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 [email protected], can be contacted from Monday through Friday 8 AM to 5 PM, 574-372-1570.
Quantity in commerce: 8
Distribution: Foreign Distribution in China and Australia only.
Product codes and lots: Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0823-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0822-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17
Z-0823-2015	Class II	Terminated	Voluntary: Firm initiated	2014-12-24	2014-12-17

Product code JDI

K130610Class IISirius Femoral StemBiomet, Inc. / cleared 2013-08-30

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)