ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting… — Class I medical device recall Z-1052-2013
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2013-04-24, distributed nationwide. With regards to ShapeMatch Cutting Guides using MRI Imaging, Stryker Orthopaedics has become aware that there
| Recall number | Z-1052-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2012-11-08 |
| Classified | 2013-04-12 |
| Reported by FDA | 2013-04-24 |
| Terminated | 2021-01-11 |
| Distributed | Nationwide (US) |
| Quantity | 7,868 units |
| Model numbers | TR7100-L, TR7100-R |
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 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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1052-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.