Device recall
Z-0384-2012: Product is 65mm Flexible Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW…
FDA device recall · Class II · Walter Lorenz Surgical, Inc.
Key facts
| Recall number (Z-number) | Z-0384-2012 |
|---|---|
| Recall event | 34843 |
| Product | Product is 65mm Flexible Tube***NON-STERILE PRODUCT***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN." W.LORENZ SURGICAL***WALTER LORENZ SURGICAL, INC. 1520 TRADEPORT DRIVE , REPLY TO POST OFFICE BOX 18009, JACKSONVILLE, FLORIDA 32229-8009 USA, 1-800-874-7711… |
| Product code | JEY |
| Recalling firm | Walter Lorenz Surgical, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 12, 2011 |
| 510(k) numbers | K002083 |
| FEI number | 1032347 |
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