Device recall
Z-2634-2011: ***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, FL, USA…
FDA device recall · Class II · RTI Biologics, Inc.
Key facts
| Recall number (Z-number) | Z-2634-2011 |
|---|---|
| Recall event | 58887 |
| Product | ***Processed at: Regeneration TECHNOLOGIES, INC. Alachua, FL, USA 32615***Distributed by: SpinalGraft Technologies, LLC 4340 Swinnea Road STE 39 Memphis, TN 38118***OSTEOFIL DBM Paste, 5cc Tissue ID: 321933 Reorder: 002405 Lot #(Donor ID): 101050353 Expiration: 02/21/2013***STERILE***" Bone Void… |
| Product code | MQV |
| Recalling firm | RTI Biologics, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 24, 2012 |
| 510(k) numbers | K043420 |
| FEI number | 3002719998 |
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