Z-1297-2024 Class II Ongoing
FDA device recall Z-1297-2024 was initiated by Waldemar Link GmbH & Co. KG (Mfg Site) on Feb 6, 2024 and is designated Class II. 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… The recall status is ongoing. Affected quantity: 34 units.
Recall Details
- Product Type
- Devices
- Report Date
- Mar 20, 2024
- Initiation Date
- Feb 6, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 34 units
Product Description
SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented
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 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.
Code Information
Product Code (UDI/DI): 127-740/17 (04026575241620) , 127-740/26 (04026575241637) , 127-741/17 (04026575241651) , 127-741/26 (04026575241644) , 127-742/17 (04026575241675) , 127-742/26 (04026575241682) , 127-743/17 (04026575241705) , 127-743/26 (04026575241699) , 127-744/17 (04026575241712) , 127-744/26 (04026575241729) , 127-745/17 (04026575241743) , 127-745/26 (04026575241736) , 127-746/17 (04026575241750) , 127-746/26 (04026575241767) , 127-747/17 (04026575241781) , 127-747/26 (04026575241774) , 127-748/17 (04026575241798) , 127-748/26 (04026575241804) , 127-749/17 (04026575241828) , 127-749/26 (04026575241811), 127-750/17 (04026575241835) , 127-750/26 (04026575241842) , 127-751/17 (04026575241859) , 127-751/26 (04026575242597) , 127-752/17 (04026575241866) , 127-752/26 (04026575241873) , 127-753/17 (04026575241897) , 127-753/26 (04026575241880) , 127-760/17 (04026575241347) , 127-760/26 (04026575241354) , 127-761/17 (04026575241378) , 127-761/26 (04026575241361) , 127-762/17 (04026575241385) , 127-762/26 (04026575241392) , 127-763/17 (04026575241415) , 127-763/26 (04026575241408) , 127-764/17 (04026575241422) , 127-764/26 (04026575241439) , 127-765/17 (04026575241453) , 127-765/26 (04026575241446), 127-766/17 (04026575241460) , 127-766/26 (04026575241477) , 127-767/17 (04026575241491) , 127-767/26 (04026575241484) , 127-768/17 (04026575241507) , 127-768/26 (04026575241514) , 127-769/17 (04026575241538) , 127-769/26 (04026575241521) , 127-770/17 (04026575241545) , 127-770/26 (04026575241552) , 127-771/17 (04026575241576) , 127-771/26 (04026575241569) , 127-772/17 (04026575241583) , 127-772/26 (04026575241590) , 127-773/17 (04026575241613) , 127-773/26 (04026575241606);
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1297-2024
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026