Endo-Model SL Knee Prosthesis System 16-2840/02Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04026575359233), received between Nov 10, 2022 and Jun 24, 2026 — classified as 12 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (11 reports).

1 FDA recall record name this device's identifier, 1 still open.

15 other recalls cover devices cleared under the same FDA submission (K151008); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Recalls naming this device

1. Jan 12, 2026Class IIOpen, Classified

   The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

   Z-1513-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryJun 24, 2026Fracture

  BREAKAGE OF THE CONNECTION COMPONENT [CUSTOMER].

  Patient problems: Insufficient Information

  MAUDE report 25606416 ↗
• MalfunctionJan 13, 2026Crack; Fracture

  DURING IMPLANTATION IT WAS NOTICED THAT THE IMPLANT HAD BEEN DELIVERED WITH A PLATEAU SCREW WHOSE BUSHING HAD DETACHED FROM THE SCREW SHAFT DUE TO A LONGITUDINAL CRACK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24050694 ↗
• InjurySep 2, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  UNKNOWN EVENT DATE. NOTIFICATION FROM REPRESENTATIVE M. D. THAT THE DOCTOR WILL BE REVISING A CONPONENT PREVIOUSLY IMPLANTED ON (B)(6) 2023, BECAUSE OF DISASSOCIATION. HE WILL ONLY BE REPLACING THE HINGE AND THE BUSHINGS. REVISION WILL TAKE PLACE ON (B)(6) 2025. [CUSTOMER]

  Patient problems: Insufficient Information

  MAUDE report 22932054 ↗
• InjuryApr 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT CAME IN FOR A CHECK-UP WITH PAIN. UNSTABLE KNEE JOINT. [CUSTOMER].

  Patient problems: Pain

  MAUDE report 21924098 ↗
• InjuryApr 11, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  DISASSEMBLY FAILURE OF THE IMPLANT HINGE. [CUSTOMER].

  Patient problems: Insufficient Information

  MAUDE report 21823493 ↗
• InjurySep 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTIFIED BY (B)(6) ON (B)(6) 2024, THAT A REVISION OF A DISASSOCIATED CONNECTION COMPONENT ORIGINALLY IMPLANTED ON (B)(6) 2018, WAS PERFORMED BY DR. (B)(6). ON (B)(6) 2024. IMAGES INCLUDED, ONE SHOWING EXPLANTED COMPONENTS WITH SET SCREW THAT IS PROUD AND NOTIFIED THAT THIS IS HOW IT LOOKED UPON REMOVAL. REVISION SURGERY WAS SUCCESSFUL. [CUSTOMER].

  Patient problems: Failure of Implant

  MAUDE report 20142862 ↗
• InjurySep 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTIFIED ON 2024-08-14, THAT A REVISION OF A DISASSOCIATED CONNECTION COMPONENT ORIGINALLY IMPLANTED ON (B)(6) 2018, WAS PERFORMED BY DR. (B)(6) ON (B)(6) 2024.

  Patient problems: Joint Laxity

  MAUDE report 20140136 ↗
• InjurySep 4, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A REVISION DUE TO DISLOCATION AT THE CONNECTION COMPONENT OCCURRED ON (B)(6) 2024. ORIGINALLY IMPLANTED ON (B)(6) 2023.

  Patient problems: Joint Laxity

  MAUDE report 20140043 ↗
• InjuryAug 30, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A REVISION DUE TO DISLOCATION AT THE CONNECTION COMPONENT OCCURRED ON (B)(6)2024. ORIGINALLY IMPLANTED ON (B)(6) 2023. [CUSTOMER].

  Patient problems: Failure of Implant

  MAUDE report 20105139 ↗
• InjuryJan 19, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  NOTIFIED ON 12/19/23 BY (B)(6) REGARDING A REVISION CASE WITH DR. (B)(6) ON (B)(6) 2023 FOR WHAT WAS THOUGHT TO BE A FAILED CONNECTION COMPONENT. AT SURGERY, IT WAS FOUND THAT THE CONNECTION COMPONENT WAS INTACT BUT THE PLASTIC BEARINGS WERE BROKEN IN THE FEMUR. THE REVISION REPLACED THE CONNECTION COMPONENT AND BEARINGS AND THE OUTCOME WAS SUCCESSFUL. INITIAL SURGERY DATE WAS (B)(6) 2022 WITH SAME SURGEON. EXPLANTED DEVICES HAVE BEEN DISCARDED. [CUSTOMER].

  Patient problems: Failure of Implant

  MAUDE report 18542327 ↗
• InjuryDec 12, 2023Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth; Detachment of Device or Device Component; Loosening of Implant Not Related to Bone-Ingrowth

  AS REPORTED BY REPRESENTATIVE T.A ON (B)(6) 2023 , A PATIENT PRESENTED TO THE EMERGENCY ROOM ON WEDNESDAY ON (B)(6) 2023 AND FOUND TO HAVE A DISLOCATED ENDO SL COMPONENT. REVISION SURGERY TOOK PLACE ON (B)(6) 2023 AND WAS VERY SUCCESSFUL. REPRESENTATIVE STATED THAT THE EXPLANTED BUSHINGS WERE "DESTROYED".

  Patient problems: Failure of Implant

  MAUDE report 18309046 ↗
• InjuryOct 18, 2023Detachment of Device or Device Component; Naturally Worn; Detachment of Device or Device Component; Naturally Worn

  WEAR OF THE BEARING SHELL IN THE FEMORAL COMPONENT.

  Patient problems: Failure of Implant; No Clinical Signs, Symptoms or Conditions

  MAUDE report 17957029 ↗
• MalfunctionAug 29, 2023Positioning Failure; Positioning Failure

  SET SCREW OF THE CONNECTION COMPONENT COULD NOT BE SCREWED IN. THE COUPLING HAS DECOUPLED AND OPENED. THE SET SCREW COULD NOT BE UNSCREWED FROM THE DEVICE. [TRANSLATED DESCRIPTION FROM CUSTOMER].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17643282 ↗
• MalfunctionAug 29, 2023Activation Failure; Activation Failure

  CONNECTION COMPONENT AXIS DID NOT PROPERLY DEPLOY DURING SURGERY. THE AXIS AND THE PE BEARINGS WERE NOT COMPATIBLE. BOTH THE CONNECTOR AND THE BEARINGS HAVE BEEN EXCHANGED. [TRANSLATED DESCRIPTION FROM FIELD SERVICE].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641712 ↗
• MalfunctionAug 29, 2023Activation Failure; Activation Failure

  CONNECTION COMPONENT AXIS DID NOT PROPERLY DEPLOY DURING SURGERY. BY MOVING THE LEG SEVERAL TIMES (EXTENSION, FLEXION, ROTATION), THE CONNECTOR REACHED THE DESIRED POSITION IN THE INTRACONDYLAR REGION, BUT THE AXIS DID NOT DEPLOY. THE CONNECTOR HAS BEEN EXCHANGED AND THE COUPLING WAS SUCCESSFUL AT THE FIRST ATTEMPT. [TRANSLATED DESCRIPTION FROM FIELD SERVICE].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641711 ↗
• MalfunctionApr 5, 2023Activation Failure; Activation Failure

  CONNECTION PROBLEM.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 16685919 ↗
• InjuryNov 10, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  AS NOTIFIED BY (B)(6). TO COMPLAINTS ON (B)(6) 2022, SURGERY ON (B)(6) 2022, A REVISION OF SL HINGE DFR DISASSOCIATED OUT OF FEMUR. THROUGH TEXT, INFORMATION AS FOLLOWS: PATIENT FELL AND TWISTED KNEE BADLY. NO FAULT OF IMPLANT. X-RAY (ATTACHED) SHOWS FEMUR WAS IN A GREAT DEAL OF HYPER EXTENSION. WAITING INFORMATION ON RETURN OF EXPLANTS. UPDATE (B)(6) 2022: NOTIFIED BY THE REPRESENTATIVE THAT THE EXPLANTED PARTS WERE DISCARDED BY THE HOSPITAL STAFF ALTHOUGH THEY WERE INTENDED TO BE RETURNED.

  Patient problems: Fall

  MAUDE report 15769860 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151008. One submission often covers many models, so check the product and lot details in each record.

• Z-1517-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8030/12;
• Z-1516-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-2836/11;
• Z-1522-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/12;
• Z-1515-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-2835/12;
• Z-1523-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/16;
• Z-1520-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/15;
• Z-1511-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/05;
• Z-1519-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/11;
• Z-1514-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
• Z-1512-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/15;
• Z-1521-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/11;
• Z-1518-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/09;
• Z-0890-2026 · Nov 10, 2025 · Open, Classified
  Endo Model Knee Fusion Nail SK, Knee Fusion Nail, Coupling Component, right, modular, L= 68 mm, Taper 10/12. Knee component of limb salvage replacement devices.
• Z-2410-2024 · May 22, 2024 · Open, Classified
  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, 15-281
• Z-2411-2024 · May 22, 2024 · Open, Classified
  Endo Model SL Tibial Components 16-2817/02 Tibial Component, Small, W: 60mm 16-2817/05 Tibial Component, Medium, W: 65mm 16-2817/07 Tibial Component, Large, W: 75m