FDA recall Z-1297-2024

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

Product

SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented

Reason for recall

Due to two complaints, has come to our attention that additional guidance is required on the correct interpretation of the carton label Size and Type columns to avoid misinterpretation during surgery.

Distribution

US Nationwide distribution in the states of AL, AZ, CA, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, NJ, NV, PA, TN, TX, VA, WA.

Key facts

Status
Ongoing
Initiation date
2024-02-06
Report date
2024-03-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Norderstedt, N/A, Germany

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1297-2024