Device recall
Z-0937-2015: Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers…
FDA device recall · Class II · Orthovita, Inc., dBA Stryker Orthobiologics.
Key facts
| Recall number (Z-number) | Z-0937-2015 |
|---|---|
| Recall event | 69979 |
| Product | Stryker Orthobiologics Imbibe Aliquot Needle Bone Cement Needle- Model Numbers: 2110-0505 Beveled Needle, 11 gauge x 4 inch 2110-0524 Beveled Needle, 11 gauge x 6 inch 2110-0506 Diamond Needle, 11 gauge x 4 inch 2110-0529 Diamond Needle, 11 gauge x 6 inch Intended Use: Can be used in either direct… |
| Product code | KNW |
| Recalling firm | Orthovita, Inc., dBA Stryker Orthobiologics. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 28, 2015 |
| FEI number | 1000307073 |
At a glance
- None 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