Device recall
Z-1807-2010: Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar…
FDA device recall · Class II · Acumed LLC
Key facts
| Recall number (Z-number) | Z-1807-2010 |
|---|---|
| Recall event | 55410 |
| Product | Ulnar Shorting Saw Blade is labeled in part: "Congruent Bone Plates, SIZE Ulnar Shortening Saw Blade - Hub Style S, REF 80-0499-S, Material: Stainless Steel, STERILE, Rx Only, ACUMED, Hillsboro, OR, USA". The Ulnar Saw Blade is an accessory used with a Congruent Bone Plate System covered under… |
| Product code | HRS |
| Recalling firm | Acumed LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 28, 2010 |
| 510(k) numbers | K012655 |
| FEI number | 1000125930 |
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