Device recall
Z-0535-2010: Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300. Distributed…
FDA device recall · Class II · Medtronic Xomed, Inc.
Key facts
| Recall number (Z-number) | Z-0535-2010 |
|---|---|
| Recall event | 52837 |
| Product | Repose G2 Bone Screw System, Sterile, REF 76353200; Lot # 62450300. Distributed by Medtronic Xomed, Inc. Jacksonville, Florida 32216 U.S.A. The Repose G@ Bone Screw System is composed of the Repose Bone Screw (a miniature, self-tapping screw attached to polypropylene suture), the Repose Bone Screw… |
| Product code | LRK |
| Recalling firm | Medtronic Xomed, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 15, 2010 |
| 510(k) numbers | K981677 |
| FEI number | 1045254 |
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