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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Waldemar Link GmbH & Co. KG (Mfg Site) under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Waldemar Link GmbH & Co. KG (Mfg Site)
See all →- HighWaldemar Link Recalls Endo-Model Tibial Plateau Replacement Sets
FDA (Devices) · 2026-08-19
- ModerateEmbrace standard drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01
- ModerateEmbrace shoulder drill tower surgical technique lists mixed-up article numbers
FDA (Devices) · 2026-04-01
- HighLink Endo-Model plateau 15-0027/15 recalled over screw bushing fracture
FDA (Devices) · 2026-03-18
- HighLink Endo-Model SL component 16-2840/05 recalled over bushing fracture
FDA (Devices) · 2026-03-18
Same hazard · assembly defect
See all →- ModerateOctopus 4 Tissue Stabilizer incorrectly assembled tubing positions
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution Tissue Stabilizer Model TS2000 tubing assembly error
FDA (Devices) · 2026-07-01
- ModerateOctopus Evolution AS Tissue Stabilizer Model TS2500 Tubing Assembly Issue Recall
FDA (Devices) · 2026-07-01
- ModerateCardiosave battery charging station left bay screw prevents full battery insertion
FDA (Devices) · 2026-03-25
- HighMedtronic tissue stabilizer recalled after tubing was assembled in reverse
FDA (Devices) · 2026-03-04