Biomet Recalls Sirius Hip Stems Due to Packaging Mix-Up
Biomet is recalling nine Sirius Femoral Hip Stems because parts were mixed up prior to packaging and shipment.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard is a packaging mix-up without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Biomet, Inc. is recalling nine units of the Sirius Polish Cemented Stem 34B (Catalog Number: 51-199333, Lot Number Identification: 024320). The recall was initiated after the company received a complaint and conducted an investigation.
The investigation determined that the recalled parts were mixed up with Sirius Polish Cemented Stem 38C units (Catalog Number: 51-199335, Lot Number Identification: 141680, 180920) prior to packaging and shipment. This error resulted in incorrect parts being included in the shipment.
The affected devices were distributed only in China and Australia. The source text does not specify specific actions for consumers or healthcare providers, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- 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…
- Manufacturer
- Biomet, Inc.
- Hazard
- Affected units
- 9
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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