This page has been archived on the Web
Information identified as archived is provided for reference, research or recordkeeping purposes. It is not subject to the Government of Canada Web Standards and has not been altered or updated since it was archived. Please contact us to request a format other than those available.
DISTAL RADIUS PLATE SYSTEM - LOCKING SCREW SELF TAPPING W/STARDRIVE (2015-11-20)
- Starting date:
- November 20, 2015
- 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-56194
Affected Products
DISTAL RADIUS PLATE SYSTEM - LOCKING SCREW SELF TAPPING W/STARDRIVE
Reason
It was discovered that part number (212.818) and lot 7856527 of 2.4mm locking screws may contain the incorrect package insert (GP2613, VA-LCP distal radius system). The correct package insert for the above part is GP2615 (Modular Mini Fragment LCP system).
Affected products
DISTAL RADIUS PLATE SYSTEM - LOCKING SCREW SELF TAPPING W/STARDRIVE
Lot or serial number
7856527
Model or catalog number
212.818
Companies
- Manufacturer
-
Synthes USA LLC
1101 SYNTHES AVENUE
Monument
80132
Colorado
UNITED STATES