Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Open, Classified

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

FDA Recall Z-2641-2023 · Posted 2023-09-26

Recalling FirmWaldemar Link GmbH & Co. KG (Mfg Site)
Recall StatusOpen, Classified
Product CodeLPH
Date Initiated2023-07-14
Product Quantity8 units

Reason for Recall

Product is labeled with incorrect offset.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Domestic distribution to AL, NJ, NV.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K200607LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert AdaptersWaldemar Link GmbH & Co. KG · 2021-05-28

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑