Zimmer Recalls Shoulder Humeral Inserts Due to Label Discrepancies
Zimmer Inc. is correcting patient labels for 74 anatomical shoulder humeral inserts manufactured before March 2010 due to reported 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 identifies the issue as a labeling discrepancy where the printed information is stated to be correct, fitting the criteria for minor labeling errors or low-risk issues.
Plain-English summary
Zimmer Inc. is initiating a correction for 74 units of the Anatomical Shoulder Inverse/Reverse Humeral PE-Insert Sterile, Rx. The affected products were manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland, and were distributed nationwide.
The recall was initiated 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 specific nature of the discrepancy is not fully detailed in the provided excerpt.
Healthcare providers and patients should verify the reference and lot numbers of the implanted or stored devices against the recall list. The affected REF numbers are 01.04223.360, 01.04223.366, 01.04223.400, 01.04223.403, and 01.04223.406. Affected lot numbers include 2330423, 2337486, 2503675, 2335914, 2324383, 2395586, 2405596, 2465511, 2309008, and 2446964.
The recalled product
- Product
- Anatomical Shoulder" Inverse/Reverse Humeral PE-Insert Sterile, Rx
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 74
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 (14)
- REF Numbers: 01.04223.360
- 01.04223.366
- 01.04223.400
- 01.04223.403
- and 01.04223.406 Lot:2330423
- 2337486
- 2503675
- 2335914
- 2324383
- 2395586
- 2405596
- 2465511
- 2309008
- 2446964
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