Recall Z-1297-2024 ยท JDG Prosthesis, Hip, Femoral Component, Cemented, Metal
Waldemar Link GmbH & Co. KG (Mfg Site)
SPII Model Lubinus, Hip Prosthesis Stem XL Neck, cemented
| Date | Mar 14, 2024 (initiated Feb 6, 2024) |
| Status | Open, Classified |
| 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. |
| 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 complaints@linkbio.com for any questions. |
| Quantity | 34 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K953653 | LUBINUS SP II HIP SYSTEM Turnkey Intergration USA, Inc., Nov 6, 1995 |