Zimmer Anatomical Shoulder Fracture Humeral Head Label Correction
Zimmer, Inc. is correcting patient labels for 26 Anatomical Shoulder Fracture Humeral Head units due to discrepancies in reference and lot numbers.
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, but the source text explicitly states that the information printed on the product label is correct and the issue is a labeling discrepancy. This aligns with the rubric for minor labeling errors or low-risk issues.
Plain-English summary
Zimmer, Inc. is initiating a correction for 26 units of the Anatomical Shoulder Fracture Humeral Head. These products were manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland. The recall is limited to specific reference numbers (01.04227.400, 01.04227.405, 01.04227.480, and 01.04227.485) and lot numbers (2352153, 2358721, 2366101, 2525804, 2494527, 2523912, 2385885, and 2441471).
The correction is being made after the company received four complaints regarding a discrepancy between the product patient labels and the product labels concerning reference and lot numbers. The source text notes that while the information printed on the product label is correct, the discrepancy was identified in the patient labels.
The affected products were distributed nationwide. Healthcare providers and patients should verify the reference and lot numbers of their devices against the list provided in the recall notice. If a device matches the affected codes, it should be reported to Zimmer, Inc. for label correction.
The recalled product
- Product
- Anatomical Shoulder" Fracture Humeral Head
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 26
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 (11)
- REF Numbers: 01.04227.400
- 01.04227.405
- 01.04227.480
- and 01.04227.485 Lot 2352153
- 2358721
- 2366101
- 2525804
- 2494527
- 2523912
- 2385885
- 2441471
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 Plastic Breakage Recall
FDA (Devices) · 2026-07-01
- HighZimmer Off-Axis Alliance Glenoid Reamer Guide recalled for breakage
FDA (Devices) · 2026-07-01
- HighZimmer Shoulder Reamer Guide System 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 Off-Axis Comprehensive Shoulder System Reamer Guide Recall
FDA (Devices) · 2026-07-01
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- 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
- ModerateZimmer Biomet Recalls Humeral Stems Due to Incorrect Lot Number Etching
FDA (Devices) · 2018-03-21
- ModerateZimmer Sidus Stem-Free Shoulder Humeral Head Recall for Incorrect Labeling
FDA (Devices) · 2019-10-09
- ModerateZimmer Biomet Recalls Hip Fracture Stem Due to Internal Label Error
FDA (Devices) · 2018-01-10
- ModerateZimmer Recalls Distal Medial Humeral Locking Plates Due to Labeling Error
FDA (Devices) · 2013-09-04
- ModerateZimmer Manufacturing Recalls Sterile Femoral Heads Due to Sealer Calibration Issues
FDA (Devices) · 2016-03-23
- HighZimmer Manufacturing Recalls Hip Femoral Heads Due to Calibration Issues
FDA (Devices) · 2016-03-23