Set Screw 5.5 mm Rod - Model #7703-1600. Product Usage: The titanium alloy set screw is used to seat a 5.5 mm titanium a
FDA device recall Z-1146-2015 · posted 2015-02-24 · Terminated
Recall details
- Recalling firm
- Biomet Spine, LLC
- Reason for recall
- Biomet Spine LLC is recalling the Set Screw 5.5 mm Rod due to the set screw being out of specification
- Action taken
- Biomet Spine LLC (formerly Lanx) sent an Urgent Recall Notification letter to affected customers. The letter identified the affected product, problem, and actions to be taken. For questions contact Lanx Customer Service.
- Root cause
- Process control
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 1999
- Distribution
- Worldwide Distribution - US Nationwide in the states of: AZ, CA, CO, CT, FL, GA, HI, IA, ID, IN, KY, LA, MA, MD, MI, MO, NC, NE, NY, OH, OR, PA, TN, TX, VA, WI. and the countries of: Italy, and Mexico
- Date initiated
- 2012-11-30
- Date posted
- 2015-02-24
- Date terminated
- 2015-05-22
- 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 SPINAL FIXATION SYSTEM (K122145) | Lanx, Inc. | 2012-08-17 |