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

Recall Insight

This FDA Devices action (record #Z-0749-2024) was formally reported on January 24, 2024, with the manufacturer initiating the action on November 30, 2023. It is classified under Moderate severity (Class II), with a current status of Ongoing. Waldemar Link GmbH & Co. KG (Mfg Site) is listed as the recalling firm, operating out of Norderstedt, N/A. Federal records indicate 1 unit units are affected.

The documented reason for this recall is: 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 ex… Distribution data in the federal record shows the product reached: US Nationwide distribution in the state of NH.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices and 1 involve the same firm, Waldemar Link GmbH & Co. KG (Mfg Site). That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 2 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.