Waldemar Link GmbH & Co. KG (Mfg Site): 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.

Is my product affected?

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.

• UPC 04026575316281
• UPC 04026575316298
• UPC 04026575316304

Check against the official notice below — it lists the full affected range.

What happened

Waldemar Link GmbH & Co. KG is recalling 3,785 units of Endo Model Modular Rotational Tibia orthopedic prostheses in small, medium, and large sizes due to a risk that blind screws of the modular tibial component cannot be loosened during surgery. This defect may require surgeons to change their surgical procedure, which could extend the length of the operation. The affected devices were distributed domestically across 15 U.S. states and internationally across numerous countries.

The recall affects specific lot and serial numbers manufactured between April 2021 and November 2021. Consumers can identify affected products using the Universal Device Identifier (UDI) numbers and lot/serial numbers listed in the recall record. The source does not specify a remedy for consumers.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

There 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.

Details from the source

Reason for recall: There 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. Distribution: Domestic 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 Quantity: 3785 Lot/code info: UDI-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

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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