Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Cordera Hip System

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 2 Device Recall Cordera Hip Systemsee related information
Date Initiated by FirmMarch 25, 2025
Date PostedApril 15, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1569-2025
Recall Event ID 96606
510(K)NumberK202484 
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Productrestor3d Cordera Hip System. ACETABULAR LINER GRP C 36MM LIP. Model Number: HDL-060-C22L-000101 Acetabular Liner for Cordera Hip System
Code Information Model Number: HDL-060-C22L-000101 UDI-DI: M572HDL060C22L011. Lot: 1788258
Recalling Firm/
Manufacturer		 Conformis Inc.
600 Research Dr
Wilmington MA 01887-4437
For Additional Information ContactBrianna Prindle
+1-786-5210501
Manufacturer Reason
for Recall		The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
FDA Determined
Cause 2		Labeling Change Control
ActionOn about 03/25/2025, Conformis notified consignees via email with letter titled "URGENT: MEDICAL DEVICE RECALL." Consignees were instructed to examine inventory, quarantine any affected units on hand, and make arrangements to return the product. Additionally, consignees were asked to complete and return the response portion of the letter.
Quantity in Commerce16
DistributionUS Nationwide distribution in the states of CA, FL, NV, TN.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = LPH
-
-