Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140

Recall Initiated

September 16, 2019

Recall Number

Z-0828-2020

Quantity

190 units

Reason for Recall

Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded

Distribution

Nationwide

Lot / Code Info

Lot number(s) : 18G0368; 19H0009; 18F0138; 18G0038

Root Cause

Process control

Action Taken

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