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RCI ACL Fixation Screw
- Starting date:
- January 28, 2017
- Posting date:
- February 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-62208
Reason
Smith & Nephew is initiating a voluntary field corrective action/recall of various batches of the RCI screw due to a carton label error. The carton label incorrectly identifies the screw as a "reverse thread" screw. The screw presented in the package is a standard thread screw, which is correctly identified on the inner pouch label. In the event the screw is presented for use, the user would notice that the device is not a reverse thread screw. The user would replace the screw or use the provided screw to complete the procedure using a clockwise rotation.
Affected products
RCI ACL Fixation Screw
Lot or serial number
- 50576152
- 50604301
- 50617125
Model or catalog number
7209409
Companies
- Manufacturer
-
Smith & Nephew, Inc., Endoscopy Division
150 Minuteman Road
Andover
01810
Massachusetts
UNITED STATES