Z-2066-2023Class II

LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for...

Name: Z-2066-2023 LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for...
Creator: Waldemar Link GmbH & Co. KG (Mfg Site)
Published: 2022-12-23
License: https://open.fda.gov/license/

Waldemar Link GmbH & Co. KG / initiated 2022-12-23 / Open, Classified

FDA source

Waldemar Link GmbH & Co. KG (Mfg Site) began a recall of LinkSymphoKnee Distal Femoral Augment - Tilastan - Size 7-8, Medial-Right/Lateral Left, 5mm- Intended for primary and revision total knee replacement in... on 2022-12-23. FDA classified it as Class II and gives the reason as "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)". As of 2026-09-10, the recall status on record is Open, Classified.

Recall record

Recall number: Z-2066-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-12-23
Posted: 2023-07-03
Recalling firm: Waldemar Link GmbH & Co. KG
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
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: 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).
FDA 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: [email protected]
Quantity in commerce: 20 units
Distribution: US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.
Product codes and lots: UDI-DI: 04026575257379 Lot Number: 2123225

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2066-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2066-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03
Z-2067-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-07-12	2023-07-03

Product code JWH

K202924Class IILinkSymphoKnee SystemWaldemar Link GmbH & Co. KG / cleared 2021-05-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)