Drug recall
Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored…
FDA recall event 70056 · Class II · Biomet Spine, LLC
Key facts
| Event ID | 70056 |
|---|---|
| Recall numbers | Z-0982-2015 |
| Recalling firm | Biomet Spine, LLC |
| Product type | Devices |
| Products | Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retractable Drills are used with the Timberline MPF System to establish access into… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The outer diameter of the Drill shaft is oversized; thereby, resulting in interference fit when inserting the Drill into the Fixed or Variable Sleeve Assembly. |
| Initiation date | Aug 22, 2013 |
| Report date | Jan 21, 2015 |
| Termination date | Mar 13, 2015 |
| City | Broomfield |
| State | CO |
| Country | United States |
| FEI number | 3004485144 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: