FDA recall Z-0749-2024

Waldemar Link GmbH & Co. KG (Mfg Site) · Class II · device

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

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

Distribution

US Nationwide distribution in the state of NH.

Key facts

Status
Ongoing
Initiation date
2023-11-30
Report date
2024-01-24
Voluntary/Mandated
Voluntary: Firm initiated
Location
Norderstedt, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0749-2024