Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130
Recall
- Recall Number
- Z-0827-2020
- Event Number
- 84595
- FEI Number
- 1000432246
- Product Code
- KWP
- Status
- Open, Classified
- Root Cause
- Process control
- Initiated
- September 16, 2019
- Address
- Medicrea International 5389 Route De Strasbourg Vancia Rillieux La Pape France
Description
Medicrea Pass LP Trocar K-wire 01.6mm x 500mm-Nitinol Product reference : A06010130
Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded
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 : [email protected]
Nationwide
30 units