Timberline Anchored Lateral Fixed Retractable Sleeve Model No. 8630-0205. Timberline Anchored Lateral Fixed Retractable
FDA device recall Z-0983-2015 · posted 2015-01-15 · 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.
- Action taken
- The firm, Lanx, sent a letter to their Consignees/customers dated October 15, 2013. The letter describes the product, problem and actions taken. Lanx and their distributors replaced the affected inventory with conforming product. Please contact Chief Compliance Officer at 303-501-8534 or by email: Randy.fesmire@lanx.com if you have any questions regarding this recall.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- OVD
- Quantity affected
- 14 units
- Distribution
- US Distribution to states of: AZ, CA, NY, TN and TX including PR.
- 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 |