ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are intended to be used as patient-specific surgi
FDA device recall Z-1052-2013 · posted 2013-04-12 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- 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.
- Action taken
- Stryker sent Product Correction Bulletins on 11/8/2012 dated 11/9/2012 and 11/19/2012 to all affected customers. Stryker sent an updated Urgent Medical Device Product Notification letters and Acknowledgement letters dated 1/24/2013 through 1/28/2013 to all affected customers via Fed Ex with return receipt: The letter identified the affect product, problem, potential hazards, risk mitigating factors and actions to be taken. For questions call 201-831-6878. Stryker issued press release on 4/10/2013.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MBH
- Quantity affected
- 7868 units
- Distribution
- USA Nationwide Distribution
- Date initiated
- 2012-11-08
- Date posted
- 2013-04-12
- Date terminated
- 2021-01-11
- Location
- Mahwah, NJ
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SHAPEMATCH CUTTING GUIDE (K122053) | Stryker Corp. | 2012-10-24 |
| STRYKER PATIENT SPECIFIC CUTTING GUIDE (K110533) | Stryker Corp. | 2011-05-19 |