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U.S. Department of Health and Human Services

Class 2 Device Recall LINK BiMobile Dual Mobility System EPoly Liner for 28mm Head, 70mm Shell

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  Class 2 Device Recall LINK BiMobile Dual Mobility System EPoly Liner for 28mm Head, 70mm Shell see related information
Date Initiated by Firm January 22, 2024
Date Posted February 29, 2024
Recall Status1 Open3, Classified
Recall Number Z-1219-2024
Recall Event ID 93944
510(K)Number K190535  
Product Classification Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
Product LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting diseases, fractures or defects of the hip joint or proximal femur.
Item Number: 184-280/12
Code Information UDI-DI: 04026575230747 Lot Numbers: 2334253, 2325426
Recalling Firm/
Manufacturer		 Waldemar Link GmbH & Co. KG (Mfg Site)
Oststr. 4-10
Norderstedt Germany
For Additional Information Contact SAME
494053995150
Manufacturer Reason
for Recall		 Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
FDA Determined
Cause 2		 Under Investigation by firm
Action LinkBio Corp issued Urgent: Medical Device Recall letter via email on 1/22/24 to Distributors. Letter states reason for recall, health risk and action to take: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801 Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions.
Distribution Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the countries of Germany, Switzerland.
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 = LZO and Original Applicant = Waldemar Link GmbH & Co. KG
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