Zimmer Biomet Recalls OSS Cemented IM Stem Due to Labeling Error
Zimmer Biomet is recalling specific OSS Cemented IM Stem units because the internal patient label may be incorrect, although the outer box and product itself are correctly identified.
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 and involves a labeling error without reported injuries or illnesses, fitting the criteria for moderate severity associated with minor labeling errors or low-risk issues.
Plain-English summary
Zimmer Biomet, Inc. is recalling the OSS CEMENTED IM STEM 12X150, model # 150366, under FDA recall number Z-0303-2018. The recall is limited to units with Lot Number 71180. The issue involves a potential labeling error where the patient label inside the product box may be incorrect. The source text confirms that the outer box label and the actual product are correctly identified.
The affected devices were distributed nationwide in the United States, as well as internationally in Argentina, the Netherlands, and Canada. This recall is classified as Class II by the FDA. The source text does not report any illnesses, injuries, or deaths associated with this labeling error.
Healthcare providers and patients should verify the product identification against the outer box label to ensure the correct device is used. Since the internal patient label may be inaccurate, reliance on the outer box and product identification is necessary to avoid potential mix-ups.
The recalled product
- Product
- OSS CEMENTED IM STEM 12X150, model # 150366
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
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)
- Lot Number: 71180
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by Zimmer 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 10 products in this recall →Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · mis labeling
See all →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02