Recall Z-1126-2019— ulrich medical USA Inc
Class II · Terminated
Class II FDA medical device recall by ulrich medical USA Inc, initiated 2019-03-08, terminated 2020-07-10. It names 3 FDA 510(k) clearances: K161032, K123717, K102853. Product: ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.. Reason: Certain Torque Limiting Handles in the field are beyond their 3 year calibration life..
- Recalling firm
- ulrich medical USA Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-03-08
- Terminated
- 2020-07-10
- Firm location
- Chesterfield, MO, United States
510(k) clearances named in this recall
3 on FDA's record- K161032 — neon3 universal OCT spinal stabilization
- K123717 — UCENTUM
- K102853 — FLAMENCO SPINAL FIXATION SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
Reason for recall
Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.
Data sourced from openFDA. This site is unofficial and independent of the FDA.