Z-1219-2024Class II

LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with...

Name: Z-1219-2024 LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with...
Creator: Waldemar Link GmbH & Co. KG (Mfg Site)
Published: 2024-01-22
License: https://open.fda.gov/license/

Waldemar Link GmbH & Co. KG / initiated 2024-01-22 / Open, Classified / root cause: labeling and UDI

FDA source

Waldemar Link GmbH & Co. KG (Mfg Site) began a recall of 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... on 2024-01-22. FDA classified it as Class II and gives the reason as "Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1219-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-01-22
Posted: 2024-02-29
Recalling firm: Waldemar Link GmbH & Co. KG
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
Product code: LZO Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
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
Root cause tag: labeling and UDI
FDA root cause: 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 [email protected] for any questions.
Distribution: Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the countries of Germany, Switzerland.
Product codes and lots: UDI-DI: 04026575230747 Lot Numbers: 2334253, 2325426

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1219-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1219-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-06	2024-02-29

Product code LZO

K190535Class IIBiMobile Dual Mobility System - E-Dur InsertsWaldemar Link GmbH & Co. KG / cleared 2019-08-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)