Zimmer Biomet Recalls Humeral Stems Due to Incorrect Lot Number Etching
Zimmer Biomet is recalling 12 Humeral Stems because two lots were commingled and etched with incorrect lot numbers. The size difference is visually recognizable to the user.
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 labeling/identification error (incorrect lot numbers) where the discrepancy is visually recognizable to the user, fitting the criteria for moderate severity without reported injuries.
Plain-English summary
Zimmer Biomet, Inc. is conducting a medical device recall for 12 units of the Humeral Stem 83mm (Size 17). These devices are intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty. The recall involves two lots of Comprehensive Humeral stems that were commingled during the manufacturing process and subsequently etched with incorrect lot numbers.
The recall is driven by a labeling and identification error rather than a material defect. The source text notes that the size difference between the two stem sizes is 1.1 inches and that it is visually recognizable by the user that the box label does not match the contents of the box. The affected units were distributed nationwide in the states of Minnesota, New Jersey, California, Texas, and North Dakota.
Healthcare providers and facilities that have received these devices should verify the lot numbers against the product packaging. If a discrepancy is found, the devices should be removed from use and returned to Zimmer Biomet for further instructions.
The recalled product
- Product
- Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 12
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 (3)
- PN: 113633
- LN: 421700
- UDI# - (01) 00880304462632 (17) 271014 (10) 421700
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