Device product
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¿ MIS Posterior Spinal Fixation System is intended to facilitate the surgical correction of non-cervical spinal deformities by providing temporary internal fixation and stabilization during bone graft healing and/or fusion mass development.
Z-0967-2013
Product summary
- Event
- Event 55155
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7
- Official record key
device-enforcement:Z-0967-2013
Official wording
Reason: The rods were incorrectly laser etched as ILLICO¿ Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length.
Code information: Lot # 635436; Part #73601-110
Distribution pattern: Worldwide Distribution - USA including CO and NC; Internationally to Belgium.
Derived failure modes
-
Unknown
The rods were incorrectly laser etched as ILLICO¿ Straight CP Tl Rods, 110mm, when they were in fact manufactured to 100mm in length.