Z-0749-2024Class II

Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total...

Name: Z-0749-2024 Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total...
Creator: Waldemar Link GmbH & Co. KG (Mfg Site)
Published: 2023-11-30
License: https://open.fda.gov/license/

Waldemar Link GmbH & Co. KG / initiated 2023-11-30 / Open, Classified / root cause: labeling and UDI

FDA source

Waldemar Link GmbH & Co. KG (Mfg Site) began a recall of Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05 on 2023-11-30. FDA classified it as Class II and gives the reason as "Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0749-2024
Classification: Class II
Status: Open, Classified
Initiated: 2023-11-30
Posted: 2024-01-18
Recalling firm: Waldemar Link GmbH & Co. KG
Product: Link Patella Glide Resection Guide- For the implantation of the Endo-Model Knee System as part of a total knee arthroplasty procedure. Product Code: 15-2530/05
Product code: FZX Guide, Surgical, Instrument
Reason for recall: Mislabeled: Angle and height of the device marked as L(large) corresponds to the small/medium dimensions due to a product mix-up. This may result in too little bone material resected and not fit correctly leading to extended surgery time
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: Link Bio Corp. issued Urgent Medical Device Recall Letter via email on 11/30/23. 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: 1 unit
Distribution: US Nationwide distribution in the state of NH.
Product codes and lots: UDI-DI :04026575245253 Lot / Serial Number: C306165

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0749-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0749-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-01-24	2024-01-18

Product code FZX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)