Device recall
Z-0961-2012: ***CAT 375-941-012***STRYKER***Arthroscopic Burr***4.0mm BARREL BUR***Hollow 12…
FDA device recall · Class II · Ascent Healthcare Solutions
Key facts
| Recall number (Z-number) | Z-0961-2012 |
|---|---|
| Recall event | 58937 |
| Product | ***CAT 375-941-012***STRYKER***Arthroscopic Burr***4.0mm BARREL BUR***Hollow 12 Flute***RED***SAMPLE LATEX-FREE***Made in the USA***Manufacturer: ASCENT HEALTHCARE SOLUTIONS***Lakeland, FL*** Lot number: 195182***Expiration Date: 11/2011. ***CAT 375-951-112***STRYKER***Arthroscopic Burr***5.0mm… |
| Product code | HRX |
| Recalling firm | Ascent Healthcare Solutions |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 9, 2012 |
| 510(k) numbers | K012605, K012635 |
| FEI number | 3002615969 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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