[Recalled] ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively a
This is an official product-safety recall record. Below are the verified details from the issuing authority, in plain language.
Recall details
| Product | ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgical instrumentation to assist in the positioning of total knee arthroplasty components intraoperatively and in guiding the marking of bone before cutting. |
|---|---|
| Brand / manufacturer | Stryker Howmedica Osteonics Corp. |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1052-2013 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 08 November 2012 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: 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.
This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.