Device recall
Z-0939-2014: ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony…
FDA device recall · Class II · RTI Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-0939-2014 |
|---|---|
| Recall event | 67246 |
| Product | ***REF 606-01-05***OPTEFORM Allograft Paste 5 cc, bone void filler of bony defects in dental and orthopedic applications.***STERILE Using Radiation. ***Rx Only***Distributor: EXACTECH 2320 NW 66th Court, Gainesville, FL 32653 USA***Manufacturer: RTI Biologicals, Inc. 11621 Research Circle, Alachua… |
| Product code | MQV |
| Recalling firm | RTI Surgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 15, 2014 |
| 510(k) numbers | K043421 |
| 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