Device recall
Z-1052-2013: ShapeMatch Cutting Guides Product Usage: The ShapeMatch Cutting Guides are…
FDA device recall · Class I · Stryker Howmedica Osteonics Corp.
Key facts
| Recall number (Z-number) | Z-1052-2013 |
|---|---|
| Recall event | 64308 |
| 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. |
| Product code | MBH |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jan 11, 2021 |
| 510(k) numbers | K110533, K122053 |
| FEI number | 3003070421 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database