Timberline Anchored Lateral Variable Retractable Sleeve LITPCR8600-2101-07, Model No. 86300204 Timberline Anchored Later
FDA device recall Z-0978-2015 · posted 2015-01-14 · Terminated
Recall details
- Recalling firm
- Biomet Spine, LLC
- Reason for recall
- The inner diameter of the Sleeve shaft is undersized, resulting in interference fit when inserting the Anchored Lateral Straight Retractable Awl or the Anchored Lateral Straight Retractable Drill into the Sleeve shaft.
- Action taken
- The firm, Lanx, sent their Consignees/customers a letter dated October 15, 2013. The letter described the product, problem and actions taken. Lanx and their distributors replaced the affected inventory with the conforming product. Please contact the Chief Compliance Officer at 303-501-8534 or by email: Randy.fesmire@lanx.com.
- Root cause
- Component design/selection
- Status
- Terminated
- Product code
- OVD
- Quantity affected
- 12 units
- Distribution
- US Distribution to states of: AZ, CA, NY, TN, and TX including PR.
- Date initiated
- 2013-08-22
- Date posted
- 2015-01-14
- 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 |