CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
FDA Recall Z-2405-2023 · Posted 2023-08-16
Recalling FirmConformis, Inc.
Recall StatusOpen, Classified
Product CodeOQG
Date Initiated2023-06-16
Product Quantity25 units
Reason for Recall
30mm screws were labeled as 25mm screws.
Firm Action
The firm initially notified the surgeon who possessed affected devices of this recall event via telephone and subsequently by email on 7/12/2023. The surgeon mailed back all affected product to Conformis to be quarantined. Sales representatives were informed of this recall event and sent all affected devices in their possession back to Conformis to be quarantined.
Root Cause
Error in labeling
Distribution Pattern
US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.