Zimmer Recalls Anatomical Shoulder Fracture Humeral Stems for Label Discrepancies
Zimmer, Inc. is correcting patient labels for 139 Anatomical Shoulder Fracture Humeral stems due to discrepancies between product and patient labels regarding reference and lot numbers.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall addresses a documentation and labeling discrepancy where the source text explicitly states the product label information is correct, fitting the rubric for documentation issues or packaging-only problems.
Plain-English summary
Zimmer, Inc. is initiating a correction for 139 Anatomical Shoulder Fracture Humeral stems manufactured before March 2010 at the Zimmer GmbH production site in Winterthur, Switzerland. The recall was initiated after the company received four complaints regarding a discrepancy between the product patient labels and the product labels with respect to reference and lot numbers.
The source text notes that while the information printed on the product label is correct, the discrepancy exists in the patient labels. The affected products were distributed nationwide.
Consumers and healthcare providers should verify the reference and lot numbers of the implanted or stored devices against the specific REF numbers and lot numbers listed in the official recall notice to determine if their products are affected.
The recalled product
- Product
- Anatomical Shoulder" Fracture Humeral stem
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 139
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 (20)
- REF Numbers: 01.04207.072
- 01.04207.082
- 01.04207.092
- 01.04207.112
- 01.04207.132
- 01.04207.142
- 01.04217.072
- and 01.04217.132. Lot 2360479
- 2373842
- 2331163
- 2401526
- 2458833
- 2360473
- 2451660
- 2387138
- 2521377
- 2342166
- 2455419
- 2342646
- 2436406
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 →- ModerateMedline Trach Tube Kit Recalled for Component Labeling Discrepancy
FDA (Devices) · 2026-09-02
- ModerateAVID Medical Recalls Halyard Total Joint Kits for Latex Labeling Deficiency
FDA (Devices) · 2026-09-02
- ModerateOlympus Recalls PowerSeal Sealer Due to Incorrect Outer Box Labeling
FDA (Devices) · 2026-09-02
- HighSura Tanmen Ramen Noodles Recalled for Undeclared Fish Allergens
FDA (Food) · 2026-09-02
- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-09-02