Z-1298-2024Class II

SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented

Name: Z-1298-2024 SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
Creator: Waldemar Link GmbH & Co. KG (Mfg Site)
Published: 2024-02-06
License: https://open.fda.gov/license/

Waldemar Link GmbH & Co. KG / initiated 2024-02-06 / Open, Classified / root cause: labeling and UDI

FDA source

Waldemar Link GmbH & Co. KG (Mfg Site) began a recall of SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented on 2024-02-06. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1298-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-02-06
Posted: 2024-03-14
Recalling firm: Waldemar Link GmbH & Co. KG
Product: SPII Model Lubinus, Long Stem Prosthesis Standard Neck, cemented
Product code: JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by firm
Action: 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 [email protected] for any questions.
Quantity in commerce: 153 Units
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.
Product codes and lots: 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);

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1298-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1296-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-20	2024-03-14
Z-1297-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-20	2024-03-14
Z-1298-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-20	2024-03-14
Z-1299-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-03-20	2024-03-14

Product code JDG

K953653Class IILubinus Sp II Hip SystemTurnkey Intergration USA, Inc. / cleared 1995-11-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)