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ACUMED Products without Health Canada Authorization (2016-07-01)
- Starting date:
- July 1, 2016
- Posting date:
- August 19, 2016
- Type of communication:
- Medical Device Recall
- Subcategory:
- Medical Device
- Hazard classification:
- Type III
- Source of recall:
- Health Canada
- Issue:
- Medical Devices
- Audience:
- General Public, Healthcare Professionals, Hospitals
- Identification number:
- RA-59846
Affected products
- CONGRUENT BONE PLATE SYSTEM - REAMER
- CONGRUENT BONE PLATE SYSTEM - DRILL GUIDE
- LOCKING CLAVICLE PLATE 8 HOLE STRAIGHT
- 1ST MCP FUSION PLATE
- PROXIMAL HUMERAL PLATE EXTRA LONG
- ACUTRAK FUSION DEVICE
- POLARUS CAP SCREW ASSEMBLY
Reason
It has come to Acumed's attention that some of its products have been distributed in Canada without a valid medical device license issued by Health Canada. Acumed is recalling these products from Canada only.
Affected products
A. CONGRUENT BONE PLATE SYSTEM - REAMER
Lot or serial number
Not Applicable
Model or catalog number
- PL-SR27
- PL-SR39
- PL-SR40
- PL-SR41
Companies
- Manufacturer
-
Acumed LLC
Corenelius Pass Road NW
Hillsboro
97124
Oregon
UNITED STATES
B. CONGRUENT BONE PLATE SYSTEM - DRILL GUIDE
Lot or serial number
Not Applicable
Model or catalog number
- PL-2127
Companies
- Manufacturer
-
Acumed LLC
Corenelius Pass Road NW
Hillsboro
97124
Oregon
UNITED STATES
C. LOCKING CLAVICLE PLATE 8 HOLE STRAIGHT
Lot or serial number
Not Applicable
Model or catalog number
- 70-0095-S
- 70-0096-S
Companies
- Manufacturer
-
Acumed LLC
Corenelius Pass Road NW
Hillsboro
97124
Oregon
UNITED STATES
D. 1ST MCP FUSION PLATE
Lot or serial number
Not Applicable
Model or catalog number
- PL-MCPL
- PL-MCPR
Companies
- Manufacturer
-
Acumed LLC
Corenelius Pass Road NW
Hillsboro
97124
Oregon
UNITED STATES
E. PROXIMAL HUMERAL PLATE EXTRA LONG
Lot or serial number
Not Applicable
Model or catalog number
- PL-PHXGL
- PL-PHXGR
Companies
- Manufacturer
-
Acumed LLC
Corenelius Pass Road NW
Hillsboro
97124
Oregon
UNITED STATES
F. ACUTRAK FUSION DEVICE
Lot or serial number
Not Applicable
Model or catalog number
- 30-0033-S
- ATF-140-S
- ATF-160-S
- ATF-180-S
- ATF-200-S
- ATF-220-S
Companies
- Manufacturer
-
Acumed LLC
Corenelius Pass Road NW
Hillsboro
97124
Oregon
UNITED STATES
G. POLARUS CAP SCREW ASSEMBLY
Lot or serial number
Not Applicable
Model or catalog number
- HR-0001-S
Companies
- Manufacturer
-
Acumed LLC
Corenelius Pass Road NW
Hillsboro
97124
Oregon
UNITED STATES