Biomet, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0823-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product 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.

Product Classification:

Class II

Date Initiated: December 2, 2014

Date Posted: December 24, 2014

Recall Number: Z-0823-2015

Event ID: 69932

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.

Status: Terminated

Product Quantity: 8

Code Information:

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

Distribution Pattern:

Foreign Distribution in China and Australia only.

Voluntary or Mandated:

Voluntary: Firm initiated