Z-1674-2023Class II

LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented...

Name: Z-1674-2023 LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented...
Creator: Linkbio Corp.
Published: 2023-04-25
License: https://open.fda.gov/license/

LinkBio Corp. / initiated 2023-04-25 / Open, Classified / root cause: packaging

FDA source

Linkbio Corp. began a recall of LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee... on 2023-04-25. FDA classified it as Class II and gives the reason as "Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left)". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-1674-2023
Classification: Class II
Status: Open, Classified
Initiated: 2023-04-25
Posted: 2023-06-01
Recalling firm: LinkBio Corp.
Product: LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision total knee replacement. Item Number: 880-325/13
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).
Root cause tag: packaging
FDA root cause: Under Investigation by firm
Action: LinkBio Corp. issued Urgent Medical Device Recall on 4/25/23 via email to Distributors. Letter states reason for recall, health risk and action to take: Please respond using the attached Distributor Reply form to indicate your understanding of this Device Recall and of the need to return the affected product. Pre-paid shipping labels will be provided once the Distributor Reply Form is returned. Please return the product as soon as possible to the following address: LinkBio Corporation 69 King St Dover, NJ 07801. Please contact LinkBio at 973-625-1333 or [email protected] for any questions.
Quantity in commerce: 11 units
Distribution: US Nationwide Distribution - AL, GA, IL, IN, LA, NV, TX
Product codes and lots: UDI-DI : 04026575258123 Lot Number: 1910003

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1674-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1674-2023	Class II	Ongoing	Voluntary: Firm initiated	2023-06-07	2023-06-01

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)