Anchored Lateral Retractable Drill, Timberline IPF IFU IFU8621-0113, Model 8630-0102. Timberline Anchored Lateral Retrac
FDA device recall Z-0982-2015 · posted 2015-01-15 · Terminated
Recall details
- Recalling firm
- Biomet Spine, LLC
- 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.
- Action taken
- Distributors and Direct Sales Reps notified via letter to return product.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- OVD
- Quantity affected
- 15
- Distribution
- Distributed in PR and the states of NY, AZ, TN, TX, and CA.
- Date initiated
- 2013-08-22
- Date posted
- 2015-01-15
- Date terminated
- 2015-03-13
- Location
- Broomfield, CO
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| LANX FUSION SYSTEM- SA (K123767) | Lanx, Inc. | 2013-03-18 |