Health product recall

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