Device recall
Z-1943-2010: BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR…
FDA device recall · Class III · Biomet Microfixation, Inc.
Key facts
| Recall number (Z-number) | Z-1943-2010 |
|---|---|
| Recall event | 54366 |
| Product | BIOMET MICROFIXATION REF: 91-6103 "1.5MM" SYSTEM HIGH TORQUE (HT), SD, X-DR, SCREW 1.5MM X 3.5MM (WXL) TITANIUM LOT 829760, ***NON STERILE PRODUCT***. Bone screws used along with implantable bone plates for oral, cranio-maxillofacial procedures. |
| Product code | JEY |
| Recalling firm | Biomet Microfixation, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Dec 15, 2010 |
| 510(k) numbers | K953385 |
| 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