FDA Medical Device Recalls (openFDA)
Waldemar Link GmbH & Co. KG (Mfg Site): LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11
- Recall number
- Z-2066-2023
- Recalling firm
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Product
- LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in skeletally mature patients. Product Code: 880-307/11
- Status
- Open, Classified
- Initiated
- 2022-12-23
- Posted
- 2023-07-03
- Terminated
- not on file
- Reason
- Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).
- Root cause
- Component change control
- Action
- LinkBio Corporation issued A Product Advisory Notice to consignees holding field inventory on 18-May-2023. The product is provided to the surgeon directly by the representative of the Distributor. Letter states reason for recall, health risk and action to take: Please ensure the surgical team is made aware of this issue before using one of the affected augments. While there is no safety impact due to this issue, there could be some confusion during assembly if the issue is not known in advance. No additional action is required by users beyond reinserting the screw in the correct orientation, and no product return is required at this time. Please contact your LinkBio Sales or Customer Service representative or the contact for any questions: Jennifer Lubrecht Senior Director, Quality Management LinkBio Corporation 69 King Street Dover, NJ 07801 Mobile: +1 862.477.0370 Email: j.lubrecht@LinkBio.com
- Quantity
- 20 units
- Distribution
- US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.
- Lot, serial or model codes
- UDI-DI: 04026575257379 Lot Number: 2123225
- 510(k) numbers
- ["K202924"]
- PMA numbers
- not on file
- Product code
- JWH
- 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