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Otismed Shapematch Cutting Guide (2013-04-10)
- Starting date:
- April 10, 2013
- Posting date:
- October 28, 2013
- 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-36421
Recalled Products
Otismed Shapematch Cutting Guide
Reason
The surgical protocol for the Shapematch cutting guides did not provide sufficient information on the position of the cutting guide, the need for osteophyte / soft tissue removal, the requirement for proper axial drilling, and the need to avoid angulation and mal-alignment . The approved pre-operative plan did not provide sufficient information regarding the need for osteophyte removal. Some shapematch cutting guides may have been manufactured using pre-operative planning values that were inconsistent with the values displayed via the Otismed.net web portal.
Affected products
Otismed Shapematch Cutting Guide
Lot or serial number
All lots
Model or catalog number
- TR3100-L
- TR3100-R
Companies
- Manufacturer
-
Howmedica Osteonics Corporation
325 Corporate Drive
Mahwah
07430
New Jersey
UNITED STATES