Waldemar Link GmbH & Co. KG (Mfg Site): Medical Device Recall in 2024 - (Recall #: Z-1298-2024)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2024.

Data Source: FDA.

Product Description:

SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented

Product Classification:

Class II

Date Initiated: February 6, 2024

Date Posted: March 20, 2024

Recall Number: Z-1298-2024

Event ID: 94078

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.

Status: Ongoing

Product Quantity: 153 Units

Code Information:

Product Code (UDI/DI): 127-910/26 (04026575024872) , 127-910/35 (04026575024889) , 127-911/26 (04026575024902) , 127-911/35 (04026575024919) , 127-912/26 (04026575024933) , 127-912/35 (04026575024940) , 127-913/26 (04026575024964) , 127-913/35 (04026575024971) , 127-914/26 (04026575024995) , 127-914/35 (04026575025008) , 127-915/26 (04026575025022) , 127-915/35 (04026575025039) , 127-916/26 (04026575025053) , 127-916/35 (04026575025060) , 127-917/26 (04026575025084) , 127-917/35 (04026575025091), 127-918/26 (04026575025114) , 127-918/35 (04026575025121) , 127-919/26 (04026575025145) , 127-919/35 (04026575025152) , 127-920/26 (04026575025176) , 127-920/35 (04026575025183) , 127-921/26 (04026575025206) , 127-921/35 (04026575025213) , 127-922/26 (04026575025237) , 127-922/35 (04026575025244) , 127-923/26 (04026575025268) , 127-923/35 (04026575025275) , 127-924/26 (04026575025299) , 127-924/35 (04026575025305) , 127-925/26 (04026575025329) , 127-925/35 (04026575025336), 127-926/26 (04026575025350) , 127-926/35 (04026575025367) , 127-927/26 (04026575025381) , 127-927/35 (04026575025398) , 127-928/26 (04026575025411), 127-928/35 (04026575025428) , 127-929/26 (04026575025442) , 127-929/35 (04026575025459) , 127-930/26 (04026575025473) , 127-930/35 (04026575025480) , 127-931/26 (04026575025503) , 127-931/35 (04026575025510) , 127-932/26 (04026575025534) , 127-932/35 (04026575025541) , 127-933/26 (04026575025565) , 127-933/35 (04026575025572);

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated