Device recall
Z-1444-05: TM-300 Traction System; an Rx software driven device used for patient traction…
FDA device recall · Class III · Sammons Preston Rolyan, An Ability One Company
Key facts
| Recall number (Z-number) | Z-1444-05 |
|---|---|
| Recall event | 31492 |
| Product | TM-300 Traction System; an Rx software driven device used for patient traction; Manufactured for Sammons Preston Roylan, An Ability One Company, Bolingbrook, IL 60440, Manufactured by: ITO Co., Ltd., 3-3-3 Toyotama-Minami, Nerima-ku, Tokyo, 176-8605, Japan |
| Product code | HST |
| Recalling firm | Sammons Preston Rolyan, An Ability One Company |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 9, 2008 |
| 510(k) numbers | K992545 |
| FEI number | 1418324 |
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