Class 2 Device Recall Cancellous Bone Screw

• Date Initiated by Firm: June 16, 2023
• Date Posted: August 16, 2023
• Recall Status: Open, Classified
• Recall Number: Z-2405-2023
• Recall Event ID: 92764
• 510(K)Number: K190904 K202484 K221104
• Product Classification: Hip Prosthesis, semi-constrained, cemented, metal/polymer, + additive, porous, uncemented - Product Code OQG
• Product: CONFORMIS HIP-SCREW-6.5MM X 25MM, STERILE EO
• Code Information: Model No. HAA-030-0625-000101; UDI-DI: M572HAA0300625011; Lot No. 1232071.
• Recalling Firm/ Manufacturer: Conformis, Inc.; 600 Technology Park Dr # 400; Billerica MA 01821-4154
• For Additional Information Contact: Denise Pedulla; 781-345-9001
• Manufacturer Reason for Recall: 30mm screws were labeled as 25mm screws.
• FDA Determined Cause: Error in labeling
• 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.
• Quantity in Commerce: 25 units
• Distribution: US Nationwide distribution in the states of CA, FL, GA, KS, MA, NV, NY, TN, & VA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.

• 510(K) Database: 510(K)s with Product Code = OQG; 510(K)s with Product Code = OQG