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Waldemar Link GmbH & Co. KG (Mfg Site) Recall 90477

Description: Endo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.

Waldemar Link GmbH & Co. KG (Mfg Site) Recall 90477 Information

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberZ-1377-2022
Event ID90477
Event DescriptionEndo Model Modular Rotational Tibia - Small (Model No #15-2814/02), Medium (Model No #15-2814/03), and Large (Model No #15-2814/04). orthopedic prosthesis.
Product TypeDevices
DistributionDomestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN, TX, WA. Foreign distribution to Algeria Argentina Australia Austria Belgium Bulgaria Canada China Colombia Denmark Ecuador Estonia Finland France Germany Great Britain Greece Hungary India Indonesia Israel Italy Latvia Libya Lithuania Mexico Netherlands Norway Pakistan Peru Philippines Poland Romania Saudi Arabia Slovakia Slovenia Spain Sudan Sweden Switzerland Thailand Turkey Ukraine United Arab Emirates Uruguy Vietnam
Quantity3785
Recall ReasonThere is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
Device Classification20220720
Device Code InfoUDI-DI 04026575316281 (Small) 04026575316298 (Medium) 04026575316304 (Large) Serial/Lot Numbers: 210420/0762 210426/0311 210426/0363 210426/0364 210426/0374 210504/2485 210504/2552 210504/2564 210504/2566 210510/2845 210510/2846 210602/0215 210602/0265 210602/0266 210602/1068 210602/2717 210602/2721 210602/2733 210602/2769 210629/0893 210629/0919 210629/0929 210629/0967 210629/0969 210629/1046 210629/1051 210629/1054 210629/2750 210802/0663 210802/0771 210802/0841 210907/2316 210907/2317 210913/0613 210913/0622 210913/0762 210913/0797 210913/0801 210913/0809 210913/2167 211025/0391 211025/2541 211025/2543 211025/2563 211102/0426 211102/0431 211115/0220 211115/1948 211115/2111
Center Classification Date20220712
Recall Initiation Date20220524
Recalling FirmWaldemar Link GmbH & Co. KG (Mfg Site)
Initial Notification E-Mail
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