RecallDepth

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

Company
Waldemar Link Gmbh & Co. Kg (Mfg Site) Oststr. 4-10 Norderstedt Germany
Recall Initiated
January 22, 2024
Posted
February 29, 2024
Recall Number
Z-1219-2024

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

Distribution

Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the countries of Germany, Switzerland.

Lot / Code Info

UDI-DI: 04026575230747 Lot Numbers: 2334253, 2325426

Root Cause

Under Investigation by firm

Action Taken

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.

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