Zimmer Biomet Recalls Orthopedic Salvage System Porous Stem Due to Labeling Error
Zimmer Biomet is recalling specific lots of the Orthopedic Salvage System Porous Stem because the Mini Humeral Stem may be mislabeled as the Bowed IM Stem.
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, but the source explicitly states the risk is a minor surgical delay (<30 minutes) with no reported injuries or illnesses, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Zimmer Biomet, Inc. is conducting a lot-specific medical device recall for the Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394. The recall involves three total units distributed to accounts in Indiana, Maryland, Missouri, Mississippi, and New Mexico.
The investigation determined that the Mini Humeral Stem is potentially labeled as the Bowed IM Stem lot. This labeling error could result in a potential extension of surgery by less than 30 minutes if a replacement is readily available.
Healthcare providers and patients should contact Zimmer Biomet for further information regarding the recall and replacement options.
The recalled product
- Product
- Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 3
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)
- 068390
Distribution
Part of a larger recall action
This product is one of 2 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 2 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 →- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- HighByron White A-L Complex Herbal Supplement Recalled for Undeclared Walnut
FDA (Food) · 2026-09-02
- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02