FDA Medical Device Recalls (openFDA)
Medicrea International: Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500
- Recall number
- Z-1234-2020
- Recalling firm
- Medicrea International
- Product
- Medicrea International Universal Counter Torque for use with the Pass TULIP [Spinal] System Ref : A22020500
- Status
- Terminated
- Initiated
- 2019-11-11
- Posted
- not on file
- Terminated
- 2020-10-14
- Reason
- Incompatible universal counter torque (A22020500) with the nut driver T30 (A22020220)
- Root cause
- Device Design
- Action
- Medicrea issued notification dated 11/11/19 via email, stating reason for recall, health risk and action to take: 1. Immediately check your internal inventory and quarantine all subject devices pending return to MEDICREA. 2. Circulate this Field Safety Notice internally to all interested/affected parties. 3. Inform MEDICREA if any of the subject devices have been distributed to other organizations. inform MEDICREA of any adverse events concerning the use of the subject devices. Complete the attached customer response form. contact person for this action is given below: Karine TROGNEUX-MEDICREA INTERNATIONAL Regulatory Affairs Manager Direct : +33(0)4.69.85.95.39 Standard : +33 (0)4.72.01.87.87. Fax - N +33 (0)04 72 01 87 88 Mail : ktrogneux@medicrea.com
- Quantity
- 3 units
- Distribution
- CA, FL
- Lot, serial or model codes
- Lot Number:19H0108 Exp.Date: 19/08/2029
- 510(k) numbers
- ["K190376"]
- PMA numbers
- not on file
- Product code
- NKB
- Firm FEI
- 1000432246
- Firm city
- Vancia Rillieux La Pape
- Firm state
- not on file
- Firm country
- France
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28