Endo-Model SL Knee Prosthesis System 16-2840/05Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04026575359240), received between May 22, 2023 and Aug 13, 2026 — classified as 9 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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-1511-2026 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• InjuryAug 13, 2026Difficult or Delayed Separation

  Notified that a revision to an connection component on an Endo SL was performed today with Dr. (b)(6), and there was difficulty in removing the connection component and there was damage to the femur, insert, bushings and the mechanism, with the screw almost completely worn down.The procedure was extended for approximately 30 minutes. The parts will be returned for the investigation when received. "[customer]".

  Patient problems: Insufficient Information

  MAUDE report 50233302 ↗
• InjuryMay 28, 2026Detachment of Device or Device Component

  Wear and tear of the bushings and resulting luxation of the joint. "[customer]".

  Patient problems: Insufficient Information

  MAUDE report 25314500 ↗
• InjuryFeb 4, 2025Unstable; Unstable

  JOINT INSTABILITY IN REVISION - MEGA SYSTEM C DX.[CUSTOMER]

  Patient problems: Insufficient Information; Joint Laxity

  MAUDE report 21301411 ↗
• InjuryDec 17, 2024Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component

  NOTIFIED BY J. T. ABOUT A REVISION TO AN SL KNEE, ORIGINALLY IMPLANTED ON (B)(6) 2023. COMPONENT WAS LOOSE. SEE IMAGE OF COMPONENTS IN SITU, SET SCREW SEEMS TO HAVE BACKED OUT. REVISION TOOK PLACE ON (B)(6) 2024. THIS IS THE THIRD REVISION FOR THIS PATIENT. SEE USAGE FORMS, IMAGES, AND X-RAY. [CUSTOMER].

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 20951391 ↗
• InjuryDec 3, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  NOTIFIED BY (B)(6) ABOUT A REVISION TO AN SL KNEE, ORIGINALLY IMPLANTED ON (B)(6) 2023. COMPONENT WAS LOOSE AND THE SET SCREW SEEMS TO HAVE BACKED OUT. REVISION TOOK PLACE ON (B)(6) 2024. THIS IS THE THIRD REVISION FOR THIS PATIENT.

  Patient problems: Joint Laxity

  MAUDE report 20834652 ↗
• InjuryOct 18, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  PATIENT PRESENTS WITH PAIN AND JOINT INSTABILITY. AFTER RADIOGRAPHIC EXAMINATION IT SHOWS FRACTURE OF THE PROSTHETIC COMPONENT. [CUSTOMER].

  Patient problems: Joint Laxity; Pain

  MAUDE report 20479263 ↗
• MalfunctionJun 18, 2024Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  THE CASE HAD PROCEEDED ACCORDING TO THE PLAN DELIVERED BY CUSTOMLINK AND IMPLANTS (SEE USAGE STICKERS BELOW) HAD BEEN CEMENTED IN PLACE WITH THE HINGE COMPONENT STILL TO BE INSERTED IN THE TIBIA AND ENGAGED WITHIN THE FEMUR. AS PER THE TECHNIQUE DR H. PLACED THE HINGE COMPONENT (16-2840/05 SN (B)(6) INTO THE TIBIA AND FITTED THE POLYETHYLENE ANTI-LUXATION COMPONENT. ACCESS WAS DIFFICULT DUE TO THE TIGHTNESS OF THE EXTENSOR MECHANISM (TOO TIGHT TO EVERT THE PATELLA AS PER STANDARD TKA PRACTICE SO IT WAS RETRACTED LATERALLY INSTEAD). IT WAS ALSO NOT POSSIBLE TO HAVE THE LEG FLEXED MORE THAN 90° DURING IMPLANTATION EITHER. THIS RESULTED WITH LIMITED SPACE AND IT WAS VERY DIFFICULT TO LOCATE THE HINGE COMPONENT INTO THE INTRA-CONDYLAR SLOT OF THE FEMUR. DURING THIS PROCESS OF TRYING TO LOCATE THE HINGE THE SECURING SLEEVE WAS ROTATED OUT OF ITS LOCKED POSITION BY THE PATELLA AND THE LOCATING AXIS AND SPRING ALL CAME APART. FORTUITOUSLY THE PIECES WERE CONTAINED WITHIN THE WOUND AND THE COMPONENTS ABLE TO BE PUT BACK TOGETHER. WHEN THE HINGE WAS ABLE TO BE LOCATED INTO PLACE THE LOCKING SCREW COULD NOT BE DRIVEN FORWARD INTO POSITION. DR (B)(6). BACKED THE LOCKING SCREW OUT AND UPON INS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19558632 ↗
• InjuryApr 3, 2024Degraded; Detachment of Device or Device Component; Degraded; Detachment of Device or Device Component

  NOTIFIED ON 3/6/2024 BY REPRESENTATIVE (B)(6), THAT ON (B)(6) 2024, DR.(B)(6) PERFORMED A REVISION SURGERY FOR AN ENDO SL THAT HAD A DISASSOCIATED CONNECTION COMPONENT. AT REVIEW OF PRE-OP X-RAYS IT WAS STILL UNCLEAR AS TO THE ISSUE. WHEN OPENED, IT WAS CLEAR THAT THE COMPONENTS WERE DISASSOCIATED. THE REPRESENTATIVE STATED THAT THE CONNECTION COMPONENTS PIECES WERE "EXPLODED" WITHIN THE PATIENT, THAT THEY WERE SPREAD OUT WITHIN THE JOINT. ALL THE PIECES WERE REMOVED AND THIS EXTENDED THE SURGERY APPROXIMATELY 30 MINUTES. THE PATIENT WAS REVISED TO AN ENDO W. [CUSTOMER].

  Patient problems: Failure of Implant

  MAUDE report 19031241 ↗
• InjuryMar 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  NOTIFIED ON 3/6/2024 BY REPRESENTATIVE M. PLATE, THAT ON (B)(6) 2024, DR. M. PERFORMED A REVISION SURGERY FOR AN ENDO SL THAT HAD A DISASSOCIATED CONNECTION COMPONENT. AT REVIEW OF PRE-OP X-RAYS IT WAS STILL UNCLEAR AS TO THE ISSUE. WHEN OPENED, IT WAS CLEAR THAT THE COMPONENTS WERE DISASSOCIATED. ALL THE DISASSOCIATED PIECES WERE REMOVED AND THIS EXTENDED THE SURGERY APPROXIMATELY 30 MINUTES.

  Patient problems: Joint Laxity

  MAUDE report 18880866 ↗
• MalfunctionSep 5, 2023Activation Failure; Activation Problem; Activation Failure; Activation Problem

  WHILE WE TRY TO SCREW THE TIGHTENING SCREW IN THE ROTAITING HINGE, IT WAS IMPOSSIBLE TO ADVANCE AND THE SCREW IS STUCK ALMOST AT THE MIDDLE ( WE DID TRY TO OPEN THE HINGE WITH THE FORCEPS ) AND STILL THE SCREW WASNT ADVANCED. [CUSTOMER].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17682856 ↗
• MalfunctionAug 29, 2023Activation Failure; Activation Failure

  ON 2021-09-21, DISTRIBUTOR WAS NOTIFIED THAT DURING AN SL HINGE KNEE REPLACEMENT ON (B)(6) 2021, A CONNECTION COMPONENT (PART # 16-2840/05, SN # (B)(6) PART DESCRIPTION: CONNECTION COMPONENT, ROTATIONAL VERSION, MEDIUM) DID NOT PROPERLY DEPLOY. THE SURGEON TRIED MULTIPLE TIMES TO GET THE LOCKING SCREW TO ENGAGE BUT WAS UNSUCCESSFUL. HOWEVER, A SECOND IDENTICAL DEVICE (PART # 16-2840/05, SN # (B)(6)) "WORKED PERFECTLY". AS PER THE SALES REPRESENTATIVE: "SURGERY TIME WAS ONLY EXTENDED BY A FEW MINUTES. JUST LONG ENOUGH FOR US TO GO THE STORAGE ROOM AND GET ANOTHER MEDIUM CONNECTION COMPONENT. THE CASE ENDED UP GREAT". THE COMPLAINT SAMPLE WILL NOT BE AVAILABLE FOR INVESTIGATION BECAUSE "IT FELL INTO FOUR OR FIVE SEPARATE PIECES WHEN IT FAILED AND WAS THROWN AWAY LATER". [CUSTOMER].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17641842 ↗
• InjuryMay 22, 2023Unstable; Detachment of Device or Device Component; Unstable; Detachment of Device or Device Component

  A REVISION SURGERY WAS PERFORMED BY (B)(6) ON (B)(6) 2023 BECAUSE OF A LOOSE BUSHING AND CONNECTION COMPONENT. THE REP REPORTED THAT THE COMPONENTS WERE STILL INTACT/ASSOCIATED BUT THE KNEE WAS VERY UNSTABLE. THE EXPLANTED COMPONENTS WERE DISCARDED. ORIGINALLY IMPLANTED ON (B)(6) 2020. CONNECTION COMPONENT AND BUSHINGS WERE REPLACED. SURGERY WAS SUCCESSFUL.

  Patient problems: Failure of Implant

  MAUDE report 16972144 ↗

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-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-1514-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;
• Z-1517-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8030/12;
• Z-1518-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/09;
• Z-1519-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-8521/11;
• Z-1513-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/02;
• Z-1515-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-2835/12;
• Z-1522-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/12;
• Z-1521-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/11;
• Z-1512-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-0027/15;
• Z-1516-2026 · Jan 12, 2026 · Open, Classified
  Endo-Model Replacement Plateau; Item Number: 15-2836/11;
• 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