Biomet Sirius Cemented Hip Stem Recall Due to Packaging Mix-up
Biomet is recalling eight Sirius Polish Cemented Hip Stems because parts were mixed up prior to packaging and shipment.
What this means for you
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. The hazard is a packaging mix-up (mis-labeling) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Biomet, Inc. is recalling eight units of the Sirius Polish Cemented Stem 38C (Catalog Number: 51-199335, Lot Numbers: 141680, 180920). 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 348 units (Catalog Number: 51-199333, Lot Number: 024320) prior to packaging and shipment. The affected products are double-tapered, highly polished cemented hip stems designed for primary or revision surgery.
The recall is limited to foreign distribution in China and Australia. No illnesses or injuries have been reported in the source text.
The recalled product
- 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
- Manufacturer
- Biomet, Inc.
- Affected units
- 8
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 180920
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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