ILLICO Straight CP TI Rod, -5.5MM x 110M; REF#73601-110; Qty 1; LBL-005; REV.B; RX ONLY; Alphatec Spine, Inc. The ILLICO
FDA device recall Z-0967-2013 · posted 2013-03-18 · Terminated
Recall details
- Recalling firm
- Alphatec Spine, Inc.
- Reason for recall
- The rods were incorrectly laser etched as ILLICO Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length.
- Action taken
- Alphatec Spine sent an Urgent Medical Device Recall letter dated July 6, 2011, to all affected customers. This notification described the product, problem and actions to be taken. The consignees were instructed to review their inventory to verify the affected device; abstain from use; immediately contact Alphatec Spine Sales Administration (salesadministration@alphatecspine.com) for instructions on how to return this affected product; and complete, sign and return confirmation form to Alphatec Spine, Inc., 5818 El Camino Real, Carlsbad, CA 92008. If you have any questions, call 760-431-9286.
- Root cause
- Process control
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 7
- Distribution
- Worldwide Distribution - USA including CO and NC; Internationally to Belgium.
- Date initiated
- 2011-07-06
- Date posted
- 2013-03-18
- Date terminated
- 2013-03-20
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM (K042673) | Alphatec/Nexmed | 2004-10-27 |