Zimmer Anatomical Shoulder Ball Taper Label Correction
Zimmer Inc. is correcting patient labels for Anatomical Shoulder Ball Tapers due to discrepancies in reference and lot numbers.
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 text explicitly states that the information printed on the product label is correct and the issue is a labeling discrepancy, fitting the criteria for minor labeling errors.
Plain-English summary
Zimmer Inc. is initiating a correction for Anatomical Shoulder Ball Tapers for humeral stems manufactured before March 2010 at the Zimmer GmbH production site in Winterthur, Switzerland. The recall involves 54 units distributed nationwide.
The correction is being made after the company received four complaints regarding discrepancies between the product patient labels and the product labels concerning reference and lot numbers. The source text notes that the information printed on the product label is correct.
Affected units are identified by REF Numbers 01.04227.102 and Lot Numbers 2350372, 2381792, 2398201, 2452078, and 2460783. Healthcare providers and patients should verify the labeling on these specific devices.
The recalled product
- Product
- Anatomical Shoulder" Ball taper for humeral stem
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 54
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 (6)
- REF Numbers: 01.04227.102
- Lot:2350372
- 2381792
- 2398201
- 2452078
- 2460783
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 40 recalled by Zimmer, 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 40 products in this recall →Related recalls
Same manufacturer · Zimmer, Inc.
See all →- HighZimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
- ModerateZimmer Shoulder System Reamer Guide recalled for plastic breakage
FDA (Devices) · 2026-07-01
- ModeratePersona Revision Trabecular Metal Femoral Distal Augment recalled for packaging defect
FDA (Devices) · 2026-07-01
- HighZimmer Shoulder Reamer Guide System Recalled for Plastic Breakage
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide Plastic Breakage Recall
FDA (Devices) · 2026-07-01
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