ShapeMatch Cutting Guides Product Usage: The ShapeMatch recall
ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist…
Why was ShapeMatch Cutting Guides Product Usage: The ShapeMatch recalled?
With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that there are potential issues associated with internal processes for planning cases and producing ShapeMatch Cutting Guides.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Catalog No: TR7100-L and TR7100-R Lot Code: All
- Product
- ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist…
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Quantity
- 7868 units
- Distribution
- USA Nationwide Distribution
- Recall date
- April 24, 2013
- Classification
- Class I
- Status
- Terminated
- Agency
- FDA (device)