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U.S. Department of Health and Human Services

Class 2 Device Recall Cancellous Bone Screw

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  Class 2 Device Recall Cancellous Bone Screw see related information
Date Initiated by Firm June 16, 2023
Date Posted August 16, 2023
Recall Status1 Open3, 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 2		 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 and Original Applicant = Conformis Inc.
510(K)s with Product Code = OQG and Original Applicant = ConforMIS, Inc.
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