Waldemar Link
16 federal recalls on file. We monitor every CPSC, FDA, USDA, and NHTSA notice for Waldemar Link and translate it into plain English — free weekly digest, optional same-day alerts.
- 2026-04-01FDA-DeviceClass IICheck Embrace Drill Tower instruction manual
The surgical instruction guide for the Waldemar Link Embrace Drill Tower shoulder instrument contains mixed-up article numbers in the equipment overview section. The individual surgical steps themselves are correct and safe to follow.
- 2026-04-01FDA-DeviceClass IICheck Embrace Drill Tower documentation
Waldemar Link's Embrace Shoulder Instruments Drill Tower (25mm, Item 645-081/62) was distributed with a surgical technique guide that lists incorrect article numbers in the instrument overview. The step-by-step surgical instructions themselves are correct and safe to follow.
- 2026-03-18FDA-DeviceClass IIStop using Waldemar Link Endo-Model Replacement Plateau
Waldemar Link GmbH & Co. KG is recalling specific lots of the Endo-Model Replacement Plateau (Item 15-0027/16), a surgical implant used in joint replacement procedures. The bushing on the plateau screw may detach from the screw shaft due to a crack, which could affect the implant's stability during or after surgery.
- 2026-03-18FDA-DeviceClass IICheck Endo-Model Replacement Plateau implants
Waldemar Link GmbH & Co. KG is recalling Endo-Model Replacement Plateau screws (Item Number 15-0027/12) because the bushing could detach from the screw shaft due to a crack. This could affect the stability of the implant. One affected unit has been identified outside the US.
- 2026-03-18FDA-DeviceClass IICheck your Endo-Model Replacement Plateau implant
Waldemar Link GmbH & Co. KG is recalling the Endo-Model Replacement Plateau (Item Number 15-0027/11) because the bushing on the plateau screw could detach from the screw shaft due to a crack. This could affect the stability of the implant. Two units outside the US have been identified, with no injuries reported to date.
- 2026-03-18FDA-DeviceClass IIStop using Waldemar Link Endo-Model Plateau screw
Waldemar Link GmbH & Co. KG is recalling certain Endo-Model Replacement Plateau screws (Item Number 15-8521/15) because the bushing could detach from the screw shaft due to a crack. This could affect the function of the implant. Four units have been identified outside the United States.
- 2026-03-18FDA-DeviceClass IIStop using affected Waldemar Link plateau screws
Waldemar Link GmbH & Co. KG is recalling certain Endo-Model Replacement Plateau screws (Item Number 15-8521/11) because the bushing could detach from the screw shaft due to a crack. This could affect the function of the implant. No injuries have been reported.
- 2026-03-18FDA-DeviceClass IICheck your Endo-Model Replacement Plateau implant
Waldemar Link GmbH & Co. KG is recalling certain Endo-Model Replacement Plateau implants (Item Number 15-8521/09) because the bushing on the plateau screw may detach from the screw shaft due to a crack. This could affect the stability of the implant. Eight units have been identified with this issue outside the United States.
- 2026-03-18FDA-DeviceClass IIStop using affected Waldemar Link plateau screws
Waldemar Link's Endo-Model Replacement Plateau screws (Item 15-8030/12) may have a bushing that can detach from the screw shaft due to a crack in the screw. This could affect the stability of knee replacement implants. Four units have been identified in this recall, primarily distributed outside the United States.
- 2026-03-18FDA-DeviceClass IIContact your surgeon about Waldemar Link plateau screw
Waldemar Link GmbH & Co. KG is recalling certain Endo-Model Replacement Plateau screws (Item Number 15-2836/11) because the bushing holding the screw together could fracture and detach. This affects 7 units distributed outside the United States in multiple countries. No injuries have been reported.
- 2026-03-18FDA-DeviceClass IICheck Waldemar Link knee implant screw
Waldemar Link GmbH & Co. KG is recalling a specific lot of Endo-Model Replacement Plateau knee implant screws (Item 15-2835/12, Lot 241210/1809). The bushing on the screw can potentially detach from the shaft due to a crack, which could affect the stability of the implant.
- 2026-03-18FDA-DeviceClass IICheck Endo-Model SL implant lot numbers
Waldemar Link GmbH & Co. KG is recalling specific lots of the Endo-Model SL Connection Component with PE-Plateau (Item 16-2840/07) used in orthopedic implants. The bushing on the plateau screw could detach from the screw shaft due to a longitudinal fracture, which could affect implant stability. Thirty-one units have been distributed outside the US.
- 2026-03-18FDA-DeviceClass IICheck Waldemar Link implant screw lot numbers
Waldemar Link GmbH & Co. KG is recalling specific lots of Endo-Model SL Connection Component implant screws. The bushing on the plateau screw could detach from the screw shaft due to a crack, which could affect implant stability.
- 2026-03-18FDA-DeviceClass IIStop using Waldemar Link Endo-Model Plateau screws
Waldemar Link GmbH & Co. KG is recalling Endo-Model Replacement Plateau screws (Item Number 15-0027/15) because the bushing could detach from the screw shaft due to a crack. This could affect the stability of the implant. Three units with lot number 2549190 were distributed worldwide, including in the U.S., Canada, and Europe.
- 2026-03-18FDA-DeviceClass IIStop using affected Waldemar Link implant components
Waldemar Link GmbH & Co. KG is recalling specific lots of the Endo-Model SL Connection Component (Item 16-2840/05) used in orthopedic implants. A bushing on the plateau screw could detach from the screw shaft due to a crack, which could affect implant stability. One unit was distributed in the U.S. (New Jersey); the remaining 43 units were distributed internationally.
- 2025-12-17FDA-DeviceClass IICheck Waldemar Link knee fusion nail implant
Waldemar Link knee fusion nails in certain lots were shipped with a locking screw installed incorrectly—inserted from the wrong side into the femoral component. This misalignment could affect how the device functions after implantation. Eighteen units were distributed to Alabama, Georgia, and Texas.
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