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.
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. 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.
See all 2 products in this recall →Related recalls
Same manufacturer · Biomet, Inc.
See all →- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recall for Packaging Damage
FDA (Devices) · 2026-08-12
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighBiomet Hip Stem Cement Spacer Mold Recalled for Cleaning Process Concerns
FDA (Devices) · 2020-04-15
- ModerateZimmer Biomet Recalls Echo Hip Stems Due to Potential Component Comingle
FDA (Devices) · 2018-08-22
- ModerateBiomet Hip Stem Recall for Incorrect PMMA Labeling
FDA (Devices) · 2016-01-20
- ModerateBiomet Recalls Hip Cement Spacer Molds Due to Cleaning Process Concerns
FDA (Devices) · 2020-04-15
- ModerateZimmer Biomet Ceramic Hip Prosthesis Head Lacks Stem Compatibility Information
FDA (Devices) · 2025-04-30
- HighBiomet Hip Cement Spacer Mold Recalled for Cleaning Process Concerns
FDA (Devices) · 2020-04-15