Device recall
Z-0836-2012: Package of center-drive bone screws labeled in part: "***REF: 01-7204***1.5MM"…
FDA device recall · Class III · Biomet Microfixation, Inc.
Key facts
| Recall number (Z-number) | Z-0836-2012 |
|---|---|
| Recall event | 59181 |
| Product | Package of center-drive bone screws labeled in part: "***REF: 01-7204***1.5MM" SYSTEM CENTER-DRIVE SCREW, 5/ PKG***1.5 X4MM TITANIUM***CAUTION: FEDERAL LAW RESTRICTS THIS DEVICE TO SALE BY OR ON THE ORDER OF A PHYSICIAN.***BIOMET MICROFIXATION***1520 TRADEPORT DRIVE***JACKSONVILLE, FL 32218… |
| Product code | NDJ |
| Recalling firm | Biomet Microfixation, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Jan 31, 2012 |
| 510(k) numbers | K953385 |
| FEI number | 1032347 |
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