LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Right
- Recall Initiated
- March 18, 2021
- Posted
- June 30, 2023
- Recall Number
- Z-2048-2023
- Quantity
- 16 units
Reason for Recall
The firm discovered through customer complaints that device segments may not meet specifications.
Distribution
Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia, Austria, Brazil, Finland, France, Germany, India, Italy, Spain, and United Kingdom.
Lot / Code Info
Item No. 15-2979/01; UDI-DI: 04026575328093.
Root Cause
Device Design
Action Taken
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 n.mangale@linkbio.com.