FDA Medical Device Recalls (openFDA)
Waldemar Link GmbH & Co. KG (Mfg Site): LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left
- Recall number
- Z-2049-2023
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Product
- LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 4, Left
- Status
- Open, Classified
- Initiated
- 2021-03-18
- Posted
- 2023-06-30
- Terminated
- not on file
- Reason
- The firm discovered through customer complaints that device segments may not meet specifications.
- Root cause
- Device Design
- 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 n.mangale@linkbio.com.
- Quantity
- 13 units
- 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, serial or model codes
- Item No. 15-2979/02; UDI-DI: 04026575328109.
- 510(k) numbers
- ["K143179"]
- PMA numbers
- not on file
- Product code
- KRO
- Firm FEI
- 3003386935
- Firm city
- Norderstedt
- Firm state
- not on file
- Firm country
- Germany
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28