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U.S. Department of Health and Human Services

Class 2 Device Recall MobileLink Acetabular Cup System

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  Class 2 Device Recall MobileLink Acetabular Cup System see related information
Date Initiated by Firm July 14, 2023
Date Posted September 26, 2023
Recall Status1 Open3, Classified
Recall Number Z-2641-2023
Recall Event ID 92807
510(K)Number K200607  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
Product MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
Code Information UDI-DI: 04026575182329 Item Number: 183-610/05 Lots: 210526/0781; 210526/0777; 210526/0779; 210526/0771; 210526/0772; 210526/0783; 210526/0784; 210526/0778
Recalling Firm/
Manufacturer
Waldemar Link GmbH & Co. KG (Mfg Site)
Oststr. 4-10
Norderstedt Germany
For Additional Information Contact Jennifer Lubrecht
862-4770370
Manufacturer Reason
for Recall
Product is labeled with incorrect offset.
FDA Determined
Cause 2
Under Investigation by firm
Action On July 17, 2023, firm notified consignees via email. Customers were advised to return the affected product to LinkBio. Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions.
Quantity in Commerce 8 units
Distribution Domestic distribution to AL, NJ, NV.
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 = LPH and Original Applicant = Waldemar Link GmbH & Co. KG
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