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Various Anspach devices (2014-05-08)
- Starting date:
- May 8, 2014
- Posting date:
- November 7, 2014
- 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-42061
Recalled Products
A) Craniotome 5
B) Micromax Attachments
C) Micromax Microsaw Keyless Driver
D) Micromax Microsaw Attachments
E) Adult Rotating Craniotome
F) Sagital Micro Blade
G) E max - Foot Control
H) X max - Motor
I) X max - Foot Control
J) Compact Speed Reducer
K) E max Sagittal Saw - Motor
L) Black Max High Performance Instrument System-Motors
M) Black Max High Performance Instrument System -Straight Attachments
N) Black Max High Performance Instrument System -Craniotome
O) E max 2 Plus System - Console with Irrigation
P) E max 2 Plus System - Hand Control
Q) E max 2 Plus System - Foot Control
R) OSC Micro Blade
S) Recipe M Blade
Reason
Anspach identified through internal sterility assurance level (SAL) validation testing that several attachments failed to meet 10-6 SAL when sterilized by the Sterrad 100S sterilization method that is specified in the current directions for use (DFU) and operating manuals provided with the device.
Affected products
A) Craniotome 5
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
CRANI-A
CRANI-L
CRANI-P
Companies
- Manufacturer
-
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES
B) Micromax Attachments
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
ADG
LONG
MEDIUM
SHORT
Companies
- Manufacturer
-
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES
C) Micromax Microsaw Keyless Driver
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
DRIVER
Companies
- Manufacturer
-
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES
D) Micromax Microsaw Attachments
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MEDIUM-HD
QD11
QD14
QD8
QD8-S
SHORT-HD
Companies
- Manufacturer
-
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES
E) Adult Rotating Craniotome
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
CRANI-A-R
Companies
- Manufacturer
-
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES
F) Sagital Micro Blade
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
S-SAW
Companies
- Manufacturer
-
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES
G) E max - Foot Control
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
E-FP
E-FP-DIR
Companies
- Manufacturer
-
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES
H) X max - Motor
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
XMAX
XMAX-H
Companies
- Manufacturer
-
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES
I) X max - Foot Control
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
AUTOLUBE-III
Companies
- Manufacturer
-
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES
J) Compact Speed Reducer
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
CSR60
Companies
- Manufacturer
-
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES
K) E max Sagittal Saw - Motor
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
MM-SAGITTAL
Companies
- Manufacturer
-
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES
L) Black Max High Performance Instrument System-Motors
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
BLACKMAX-N
BLACKMAX-O
Companies
- Manufacturer
-
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES
M) Black Max High Performance Instrument System -Straight Attachments
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
B-SILVER
Companies
- Manufacturer
-
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES
N) Black Max High Performance Instrument System -Craniotome
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
B-GOLD
Companies
- Manufacturer
-
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES
O) E max 2 Plus System - Console with Irrigation
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
SC2101
Companies
- Manufacturer
-
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES
P) E max 2 Plus System - Hand Control
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
EMAX2-HC
Companies
- Manufacturer
-
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES
Q) E max 2 Plus System - Foot Control
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
EMAX2-FP
Companies
- Manufacturer
-
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES
R) OSC Micro Blade
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
O-SAW
Companies
- Manufacturer
-
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES
S) Recipe M Blade
Lot or serial number
More than 10 numbers, contact manufacturer.
Model or catalog number
R-SAW
Companies
- Manufacturer
-
The Anspach Effort Inc.
4500 Riverside Drive
Palm Beach Gardens
33410
Florida
UNITED STATES