Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented Recall
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
Brand
Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany
Lot Codes / Batch Numbers
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)
Products Sold
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);
Waldemar Link GmbH & Co. KG (Mfg Site) Oststr. 4-10 Norderstedt Germany is recalling SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented due to 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 . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
Urgent Medical Device Correction (UMDC) Letters were sent via email to consignees on February 16, 2024. Actions to be taken by the customer/user: Please take note of the clarification of the carton label noted in section 2. No product return is required. Please respond using the attached Distributor Reply form to indicate your understanding of this Device Correction and of the need to correctly interpret the Size and Type columns on the label. Please contact LinkBio at 973-625-1333 or complaints@linkbio.com for any questions.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026