Recall Z-1234-2020— Medicrea International
Class II · Terminated
Class II FDA medical device recall by Medicrea International, initiated 2019-11-11, terminated 2020-10-14. It names one FDA 510(k) clearance: K190376. Product: Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500. Reason: Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220).
- Recalling firm
- Medicrea International
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2019-11-11
- Terminated
- 2020-10-14
- Firm location
- Rillieux La Pape, France
510(k) clearances named in this recall
1 on FDA's recordK-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
Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500
Reason for recall
Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)
Data sourced from openFDA. This site is unofficial and independent of the FDA.