FDA Medical Device Recalls (openFDA)
Medicrea International: Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140
- Recall number
- Z-0828-2020
- Recalling firm
- Medicrea International
- Product
- Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140
- Status
- Open, Classified
- Initiated
- 2019-09-16
- Posted
- not on file
- Terminated
- not on file
- Reason
- Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded
- Root cause
- Process control
- Action
- Medicrea International issued letter dated 9/12/19 to US Distributor stating reason for recall, health risk and action to take: 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 organisations. Please inform MEDICREA of any adverse events concerning the use of the subject devices 2. Please comply with any local laws or regulations concerning the notification of adverseevents to your National Competent Authority. 3. Complete the attached customer response form. It may be that you no longer have any physical inventory on site. Contact: 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
- 190 units
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot number(s) : 18G0368; 19H0009; 18F0138; 18G0038
- 510(k) numbers
- ["K190376"]
- PMA numbers
- not on file
- Product code
- KWP
- 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