Knee Prosthesis Tibial Component Screws Cannot Be Loosened During Surgery
The Endo Model M tibial components cannot be loosened during surgery, preventing surgeons from making necessary intraoperative adjustments. This may force unplanned procedure changes.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall with no reported injuries or illnesses. The hazard is a design defect that prevents intraoperative adjustment, creating theoretical risk of forced procedure changes and extended surgery time. Per the rubric, this is a risk-of-harm product without reported injury, scoring High (3).
Plain-English summary
The Endo Model M Tibial Components (a modular knee prosthesis system made by Waldemar Link GmbH & Co. KG) is being recalled because the blind screws that secure the modular components cannot be loosened during surgery.
This design defect prevents surgeons from disassembling the tibial component intraoperatively if they need to change their surgical approach. In such cases, surgeons may be forced to switch to cementing techniques, which prolongs the surgical procedure.
The recall affects 552 units distributed in the United States and 7,351 units distributed internationally. All units manufactured from June 1, 2022 onward are affected.
Patients who have received this prosthesis or are scheduled to receive it should contact their healthcare provider to discuss the implications. Healthcare facilities should verify their inventory against the affected product codes.
The recalled product
- Product
- Endo Model M Tibial Components Modular Knee Prosthesis System. Product codes 15-2814/01, 15-2814/02, 15-2814/03, 15-2814/04, 15-2815/11, 15-2815/12, 15-2816/11, 15-2816/12, 15-2817/11, 15-2817/12, 15-2818/11, 15-2818/12, 15-2834/01, 15-2834/02, 15-2834/03, 15-2834/04, 15-2835/11
- Manufacturer
- Waldemar Link GmbH & Co. KG (Mfg Site)
- Category
- Medical Device — Knee Prosthesis
- Hazard
- assembly-defect
- intraoperative-risk
Distribution
Distributed nationwide across the United States.
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