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Acumed Kickstand Post and Locking Drill Guide (2017-06-30)
- Starting date:
- June 30, 2017
- Posting date:
- August 14, 2017
- 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-64110
Affected Products
- Lower Extremity Congruent Plating System - Locking Drill Guide
- Acu-Loc 2 Volar Distal Radius Plating System - Kickstand Post
Reason
It has come to Acumed's attention that five kickstand post batches and one drill guide batch have potentially nonconforming threads. This non-conformance would prevent the instruments from attaching to the plate. The inability to utilize these instruments could cause health hazards such as prolonged surgery or revision surgery.
Affected products
A. Lower Extremity Congruent Plating System - Locking Drill Guide
Lot or serial number
402434
Model or catalog number
80-0384
Companies
- Manufacturer
-
Acumed LLC
Corenelius Pass Road NW
Hillsboro
97124
Oregon
UNITED STATES
B. Acu-Loc 2 Volar Distal Radius Plating System - Kickstand Post
Lot or serial number
- 397042
- 397079
- 397080
- 397081
- 403860
Model or catalog number
- 80-0718
- 80-0720
- 80-0722
- 80-0731
Companies
- Manufacturer
-
Acumed LLC
Corenelius Pass Road NW
Hillsboro
97124
Oregon
UNITED STATES