Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140
Lot Codes / Batch Numbers
Lot number(s) : 18G0368, 19H0009, 18F0138, 18G0038
Products Sold
Lot number(s) : 18G0368; 19H0009; 18F0138; 18G0038
A medical device manufacturer is recalling Medicrea Pass LP Blunt K-wire 01.6mm x 500mm-Nitinol Product reference: A06010140 due to Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Conical Cannulated Screws may not accept 1.6mm K-Wire, it cannot enter the minimum tolerance axis threaded
Recommended Action
Per FDA guidance
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
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026