Device recall
Z-1097-2016: NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm…
FDA device recall · Class II · Collagen Matrix Inc
Key facts
| Recall number (Z-number) | Z-1097-2016 |
|---|---|
| Recall event | 73206 |
| Product | NuOss XC Sinus Reference No 509-3001 (BMCU17, size 17 mm diameter x 10 mm height) Reference No 509-3002 (BMCU22, size 22 mm diameter x 12 m height) Manufacturer:- Collagen Matrix, Distributor:- ACE Surgical Supply Co, Inc, Intended use for dental surgery such as -augmentation or reconstructive… |
| Product code | NPM |
| Recalling firm | Collagen Matrix Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 21, 2017 |
| 510(k) numbers | K043034 |
| FEI number | 3003300673 |
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