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U.S. Department of Health and Human Services

Class 2 Device Recall LINK BiMobile(TM) Dual Mobility System

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  Class 2 Device Recall LINK BiMobile(TM) Dual Mobility System see related information
Date Initiated by Firm December 04, 2018
Create Date January 11, 2019
Recall Status1 Terminated 3 on June 05, 2020
Recall Number Z-0728-2019
Recall Event ID 81762
510(K)Number K171273  
Product Classification Prosthesis, hip, semi-constrained, uncemented, metal / polymer, non-porous, calcium phosphate - Product Code MEH
Product BiMobile UHMWPE Liner: ID-28mm/OD-50mm, Reference Number 184-260/02

The LINK BiMobile Dual Mobility System is indicated for patients with mobility-limiting diseases, fractures or defects which cannot be treated by conservative or osteosynthetic procedures. The device is intended for cemented and cementless use.
Code Information Lot# 1707121
Recalling Firm/
Manufacturer		 Waldemar Link GmbH & Co. KG (Mfg Site)
Oststr. 4-10
Norderstedt Germany
For Additional Information Contact Len Tokish
201-694-7331
Manufacturer Reason
for Recall		 The internal labeling included with these implants may include incorrect part numbers and could result in these incorrect labels being added to patient records.
FDA Determined
Cause 2		 Employee error
Action The firm, LinkBio Corp., Sent an "URGENT  MEDICAL DEVICE RECALL" letter dated 12/4/2018 to its customers. The letter describes the product, problem and actions to be taken. The customers are instructed to do the following: Please identify your total inventory for this product. 1) Immediately cease use and segregate the above described product. 2) Complete the enclosed Consignee Reply Form, even if you have no inventory. 3) Return the above product and a copy of the Consignee Reply Form using Federal Express Account # 007183879 to: LinkBio Corporation 101 Roundhill Drive Rockaway, NJ 07446 Recall Return Authorization #: R-2018-02 Ensure that all users of the above products within your organization and other relevant persons have been notified of this safety information. If you have transferred the products to third parties, please pass on a copy of this information or notify the contact person indicated below. Should you have any questions or require assistance, please contact 1-973-625-1333 ext. 116 between 8:00 am - 5:30 pm (M-F) EST or email: nikhil@linkbio.com at any time.
Quantity in Commerce 30
Distribution US distribution to states of: AZ, FL, GA, LA, MI, MN, TX, and WA.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = MEH and Original Applicant = Waldemar Link Gmbh & Co. KG
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