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Open, Classified

LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Right

FDA Recall Z-2046-2023 · Posted 2023-06-30

Recalling FirmWaldemar Link GmbH & Co. KG (Mfg Site)
Recall StatusOpen, Classified
Product CodeKRO
Date Initiated2021-03-18
Product Quantity21 units

Reason for Recall

The firm discovered through customer complaints that device segments may not meet specifications.

Firm Action

The firm sent recall notifications by email to consignees on 03/24/2021. Customers were asked to discontinue use of affected devices and to return any that remain in stock to LinkBio Corporation, Waldemar Link's US Distributor, immediately. Credit or replacement was issued for the returned product upon receipt. Any questions about this recall event are to be directed to Nikhil Mangale at 1-973-625-1333 ext. 116 from Monday through Friday from 8:00 am to 5:30 pm, or by email to [email protected].

Root Cause

Device Design

Distribution Pattern

Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.

Official Source

View FDA Recall →

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

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