Zimmer Recalls Metasul Durom Femoral Components Due to Labeling Discrepancies
Zimmer Inc. is correcting patient labels for 209 Metasul Durom Femoral components after complaints of reference and lot number discrepancies.
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 voluntary precautionary recalls where no physical defect or harm is indicated.
Plain-English summary
Zimmer Inc. is initiating a correction to the patient labels of Metasul Durom Femoral components. These sterile, prescription-only products were manufactured before March 2010 by the Zimmer GmbH production site in Winterthur, Switzerland. The recall involves 209 units distributed nationwide.
The action was taken 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.
Healthcare providers and patients should verify the reference and lot numbers of any implanted or stored components against the provided lists. Zimmer Inc. is the recalling firm responsible for this correction.
The recalled product
- Product
- Metasul¿ Durom¿ Femoral component Sterile, Rx
- Manufacturer
- Zimmer, Inc.
- Hazard
- Affected units
- 209
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: 01.00211.140
- 01.00211.144
- 01.00211.152
- 01.00211.154. 01.00211.156
- 01.00211.158
- and 01.00211.160. Lot: 2367454
- 2367454
- 2367455
- 2374382
- 2381632
- 2381634
- 2409055
- 2414048
- 2397713
- 2417888
- 2380622
- 2388389
- 2453506
- 2422704
- 2375235
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 →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- 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 Manufacturing Recalls Distal Femoral Components Due to Calibration Data Issues
FDA (Devices) · 2016-03-23
- ModerateZimmer Manufacturing Recalls Distal Femoral Components for Sterility Concerns
FDA (Devices) · 2016-03-23
- ModerateZimmer Distal Femoral Components Recalled for Sterility Concerns
FDA (Devices) · 2016-03-23
- HighZimmer Manufacturing Recalls Sterile Femoral Hip Implant Components
FDA (Devices) · 2016-03-23
- ModerateZimmer Manufacturing Recalls Distal Femoral Bone Fixation Appliances
FDA (Devices) · 2016-03-23
- ModerateZimmer Biomet Recalls Femoral Distal Assembly Due to Internal Labeling Error
FDA (Devices) · 2018-01-10