Skip to content
Recall Observatory FDA recall evidence

Device product

SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented

Z-1298-2024

February 06, 2024

Class II

Product summary

Firm
Waldemar Link GmbH & Co. KG (Mfg Site)
Event
Event 94078
Status
Ongoing
Classification
Class II
Quantity
153 Units
Official record key
device-enforcement:Z-1298-2024

Official wording

Reason: 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.

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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.