Integra MAYFIELD Composite Base Units Recalled for Potential Breakage
Integra LifeSciences is recalling 96 MAYFIELD Composite Series Base Units because they may break during use, posing a risk to patients during surgical procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (medical device) where injury has not yet been reported, which aligns with the 'High' severity criteria in the rubric.
Plain-English summary
Integra LifeSciences Corporation is recalling 96 units of the MAYFIELD Composite Series Base Unit Standard, Model A3101. These medical devices are intended to support patients during diagnostic examinations and surgical procedures where rigid support between the surgical table and headrest or skull clamp is necessary.
The recall was initiated because Integra determined there is a possibility that the Base Units may break during use. The affected units were distributed worldwide, including to 31 U.S. states and Belgium.
Healthcare facilities and users should stop using the affected Base Units immediately. The specific serial numbers of the recalled units are listed in the official recall documentation.
The recalled product
- Product
- MAYFIELD¿ Composite Series Base Unit Standard, Model (A3101), Rx ONLY, Integra LifeScience Corporation, 4900 Charlemar Drive, Building A, Cincinnati, OH 45227 The MAYFIELD¿ Base Units are intended to be used to support a patient during diagnostic examination and/or surgical p
- Manufacturer
- Integra LifeSciences Corp.
- Hazard
- Affected units
- 96
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)
- Model # A3101 Base Units Serial No's: SB120016
- SB120017
- SB120019
- SB120020
- SB120021
- SB120022
- SB120023
- SB120024
- SB120025
- SB120026
- SB120027
- SB120028
- SB120029
- SB120030
- SB120031
- SB120032
- SB120134
- SB120036
- SB120037
- SB120038
Distribution
Related recalls
Same manufacturer · Integra LifeSciences Corp.
See all →- HighAURORA Surgiscope System Obturator May Break or Separate
FDA (Devices) · 2025-03-12
- HighMediHoney Gel Wound Dressing Recall: Potential Induction Seal Defect
FDA (Devices) · 2025-02-19
- ModerateIntegra implantable hydrocephalus valve recalled for incorrect product description on labels
FDA (Devices) · 2025-01-29
- ModerateCODMAN CERTAS Plus programmable valve recalled for incorrect label descriptions
FDA (Devices) · 2025-01-29
- ModerateProgrammable Valve Device Recalled Due to Incorrect Product Description Labels
FDA (Devices) · 2025-01-29
Same hazard · structural failure
See all →- SevereMondraker Recalls Mountain Bicycles with ONOFF S9 Carbon Handlebars
CPSC · 2026-09-03
- HighFord F-650 SD Recall: Liftgate Platform Deck Pins May Break
NHTSA · 2026-08-20
- HighStryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization
FDA (Devices) · 2026-08-05
- HighStryker Hoffmann II Connecting Rod Micro May Crack After Cleaning and Sterilization
FDA (Devices) · 2026-08-05
- High