Aesculap Recalls Two Columbus Femoral Cutting Guides Due to Marking Error
Aesculap, Inc. is recalling two Columbus 4-IN-1 Femoral Cutting Guide Instruments because the laser markings for size identification are incorrect, although the instruments are correctly dimensioned.
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, and the hazard is a labeling error (incorrect laser marking) on a medical device. The source states the instruments are correctly dimensioned, and no injuries or illnesses are reported, fitting the criteria for a moderate severity labeling error.
Plain-English summary
Aesculap, Inc. is recalling two units of the Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (code NQ083R). The recall was initiated after the manufacturer informed the recalling firm of a potential laser marking error in the size identification on the instruments.
The instruments are correctly dimensioned, but the laser markings have been incorrectly etched. This discrepancy between the physical dimensions and the marked size could lead to the use of an incorrect instrument size during a procedure.
The product was distributed within the United States to Pennsylvania and Tennessee. No specific dates or additional distribution details are provided in the source text.
The recalled product
- Product
- Columbus 4-IN-1 Femoral Cutting Guide M3 Instrument (NQ083R)
- Manufacturer
- Aesculap, Inc.
- Hazard
- Affected units
- 2
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 (1)
- NQ083R
Distribution
Related recalls
Same manufacturer · Aesculap, Inc.
See all →- HighAesculap MINOP trocar shafts may be longer than specified
FDA (Devices) · 2026-03-11
- HighReducing converters recalled over silicone fragments detaching from sealing component
FDA (Devices) · 2025-11-05
- HighTrocar sealing units with reducer recalled over detaching silicone fragments
FDA (Devices) · 2025-11-05
- HighTrocar sealing units recalled over silicone fragments detaching from sealing component
FDA (Devices) · 2025-11-05
- HighTrocar sealing caps recalled over silicone fragments detaching from sealing component
FDA (Devices) · 2025-11-05
Same hazard · mis labeling
See all →- SevereWhite Vein Advanced Alkaloids Chewable Tablets Recall for Excess Active Ingredient
FDA (Food) · 2026-10-14
- SevereBetter Bakehouse Recalls Donutful Chocolate Dipped Vanilla Cake Donuts for Undeclared Milk
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
- HighOmnilife Recalls Offset Femoral Alignment Guides Due to Incorrect Markings
FDA (Devices) · 2015-09-02
- Highrestor3d Recalls Kinos Axiom Total Ankle Systems with Incorrect Cutting Guides
FDA (Devices) · 2026-09-23
- HighAesculap Micro Needleholder Recalled for Incorrect Size Labeling
FDA (Devices) · 2022-07-20
- ModerateAesculap Surgical Needle Recalled for Incorrect Product Code Marking
FDA (Devices) · 2023-07-26
- ModerateAesculap SIBD Trial Implants Recalled for Incorrect Part Number Etching
FDA (Devices) · 2012-08-08
- HighEncore Medical Recalls Foundation Knee System Cut Blocks Due to Marking Error
FDA (Devices) · 2015-08-05