Device recall
Z-3189-2011: Sterile Bone Cutting Burrs model IMRI-S-8NS-M labeled in…
FDA device recall · Class II · The Anspach Effort, Inc.
Key facts
| Recall number (Z-number) | Z-3189-2011 |
|---|---|
| Recall event | 58985 |
| Product | Sterile Bone Cutting Burrs model IMRI-S-8NS-M labeled in part:***IMRI-S-8NS-M***QTY: 1***3 mm Fluted Matchstick, Extends 8.9 mm,***Less Aggressive. Use with IMRI-SHORT***Attachments.***Use by 2014 08***ANSPACH***Manufacturer***Made in USA***The Anspach Effort, Inc.***4500 Riverside Drive***Palm… |
| Product code | HBC |
| Recalling firm | The Anspach Effort, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 15, 2012 |
| 510(k) numbers | K011444 |
| FEI number | 1045834 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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