Z-2641-2023Class II

MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20...

Name: Z-2641-2023 MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20...
Creator: Waldemar Link GmbH & Co. KG (Mfg Site)
Published: 2023-07-14
License: https://open.fda.gov/license/

Waldemar Link GmbH & Co. KG / initiated 2023-07-14 / Open, Classified / root cause: labeling and UDI

FDA source

Waldemar Link GmbH & Co. KG (Mfg Site) began a recall of MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination on 2023-07-14. FDA classified it as Class II and gives the reason as "Product is labeled with incorrect offset". 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-2641-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-07-14
Posted: 2023-09-26
Recalling firm: Waldemar Link GmbH & Co. KG
Product: MobileLink Acetabular Cup System, Shell/Insert Adapter for Shell 74-80mm, Insert Size F, +12mm Offset 20 degrees Inclination
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Product is labeled with incorrect offset.
Root cause tag: labeling and UDI
FDA root cause: 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 [email protected] for any questions.
Quantity in commerce: 8 units
Distribution: Domestic distribution to AL, NJ, NV.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2641-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2641-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-10-04	2023-09-26

Product code LPH

K200607Class IILINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG / cleared 2021-05-28

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)