MAYFIELD Infinity XR2 Base Unit, Low Profile Base Unit, Base Unit-Extended and MAYFIELD Spine Table Adaptor Radiolucent (2018-06-29)
- Starting date:
- June 29, 2018
- Posting date:
- July 19, 2018
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type II
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-67272
Affected products
A. MAYFIELD Infinity XR2 Base Unit
B. MAYFIELD Infinity XR2 Low Profile Base Unit
C. MAYFIELD Infinity XR2 Base Unit-Extended
D. MAYFIELD Spine Table Adaptor Radiolucent
Reason
Integra LifeSciences Corporation has initiated a voluntary recall / removal for the "standard knob assembly- xr2 base unit, a subcomponent for the following Class 1 devices: MAYFIELD Infinity XR2 Base Unit, MAYFIELD Infinity XR2 Low Profile Base Unit, MAYFIELD Infinity XR2 Base Unit-Extended and MAYFIELD Spine Table Adaptor Radiolucent. The knob assembly is fracturing/breaking at the threaded portion of the stud.
Affected products
A. MAYFIELD Infinity XR2 Base Unit
Lot or serial number
Not applicable
Model or catalog number
A2079
Companies
- Manufacturer
-
Integra Life Sciences Corporation
4900 Charlemar Drive, Building A
Cincinnati
45227
Ohio
UNITED STATES
B. MAYFIELD Infinity XR2 Low Profile Base Unit
Lot or serial number
Not applicable
Model or catalog number
A2079A
Companies
- Manufacturer
-
Integra Life Sciences Corporation
4900 Charlemar Drive, Building A
Cincinnati
45227
Ohio
UNITED STATES
C. MAYFIELD Infinity XR2 Base Unit-Extended
Lot or serial number
Not applicable
Model or catalog number
A2079E
Companies
- Manufacturer
-
Integra Life Sciences Corporation
4900 Charlemar Drive, Building A
Cincinnati
45227
Ohio
UNITED STATES
D. MAYFIELD Spine Table Adaptor Radiolucent
Lot or serial number
Not applicable
Model or catalog number
A2600R
Companies
- Manufacturer
-
Integra Life Sciences Corporation
4900 Charlemar Drive, Building A
Cincinnati
45227
Ohio
UNITED STATES