Recall Z-1052-2013— Stryker Howmedica Osteonics Corp.
Class I · Terminated
Class I FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2012-11-08, terminated 2021-01-11. It names 2 FDA 510(k) clearances: K122053, K110533. 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.. Reason: 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..
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Classification
- Class I
- Status
- Terminated
- Initiated
- 2012-11-08
- Terminated
- 2021-01-11
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
2 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.