Waldemar Link GmbH & Co. KG (Mfg Site): SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented

Hazard

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.

Details from the source

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. Quantity: 153 Units Lot/code info: 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);

UPC codes

04026575024872, 04026575024889, 04026575024902, 04026575024919, 04026575024933, 04026575024940, 04026575024964, 04026575024971, 04026575024995, 04026575025008, 04026575025022, 04026575025039, 04026575025053, 04026575025060, 04026575025084, 04026575025091, 04026575025114, 04026575025121, 04026575025145, 04026575025152, 04026575025176, 04026575025183, 04026575025206, 04026575025213, 04026575025237, 04026575025244, 04026575025268, 04026575025275, 04026575025299, 04026575025305, 04026575025329, 04026575025336, 04026575025350, 04026575025367, 04026575025381, 04026575025398, 04026575025411, 04026575025428, 04026575025442, 04026575025459

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.