Endo-Model Modular Knee Prosthesis System 15-3818/11Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04026575164028), received between Sep 10, 2024 and Sep 13, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Device Handling Problem” (1 report).

2 FDA recall records name this device's identifier, 2 still open.

20 other recalls cover devices cleared under the same FDA submission (K152431, K212742); 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 22, 2024Open, Classified

   Blind screws of the modular tibial component cannot be loosened intraoperatively,prolongation surgery due to intraoperatively change in procedure, probably to cementing technique

   Z-2410-2024 · Root cause: Process design · FDA record ↗

2. May 24, 2022Open, Classified

   There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.

   Z-1378-2022 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2024Inaccurate Delivery; Device Handling Problem; Inaccurate Delivery; Device Handling Problem

  DURING A PROCEDURE ON (B)(6) 2023, THE INCORRECT PROSTHESIS WAS SUPPLIED, AND THE INTENDED NICKELFREE LINK ROTATING HINGE PROSTHESIS WAS NOT AVAILABLE IN THE OPERATING ROOM. CONSEQUENTLY, THE SURGEON HAD TO USE A TEMPORARY PROSTHESIS AND CLOSE THE SURGICAL SITE. THE PATIENT THEN REQUIRED A FOLLOW-UP SURGERY ON (B)(6) 2023, PERFORMED BY DR. (B)(6) TO PLACE THE CORRECT PROSTHESIS. [TRANSMISSION SMITH & NEPHEW] IT WAS CONFIRMED ON (B)(6) 2024, THAT AN INCORRECT SIDE KNEE WAS ORDERED BY THE SALES REP (RIGHT INSTEAD OF LEFT) FOR AN (B)(6) 2023 SURGERY. (2 RIGHT-SIDE PARTS WERE ORDERED AND SENT AS ORDERED, SEE PN / LOTS ABOVE). IT WAS ONLY REALIZED DURING THE SURGERY, AFTER THE PROCEDURE HAD BEEN STARTED, THAT THE INCORRECT IMPLANTS HAD BEEN ORDERED, AND THE PROCEDURE COULD NOT CONTINUE. SUBSEQUENT TO THIS INCOMPLETE SURGERY, THE CORRECT PARTS WERE THEN ORDERED BY THE SALES REP AND THE NEW ORDER WAS SENT. THE PATIENT HAD TO RETURN FOR THE SECOND SURGERY, WHERE THE CORRECT LEFT-SIDE DEVICE WAS IMPLANTED ON (B)(6) 2023. [CUSTOMER].

  Patient problems: Insufficient Information

  MAUDE report 20210437 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS CONFIRMED ON (B)(6) 2024, THAT AN INCORRECT SIDE KNEE WAS ORDERED BY THE SALES REP (RIGHT INSTEAD OF LEFT) FOR AN (B)(6) 2023 SURGERY. (2 RIGHT-SIDE PARTS WERE ORDERED AND SENT AS ORDERED). IT WAS ONLY REALIZED DURING THE SURGERY, AFTER THE PROCEDURE HAD BEEN STARTED, THAT THE INCORRECT IMPLANTS HAD BEEN ORDERED, AND THE PROCEDURE COULD NOT CONTINUE. SUBSEQUENT TO THIS INCOMPLETE SURGERY, THE CORRECT PARTS WERE THEN ORDERED BY THE SALES REP AND THE NEW ORDER WAS SENT. THE PATIENT HAD TO RETURN FOR THE SECOND SURGERY, WHERE THE CORRECT LEFT-SIDE DEVICE WAS IMPLANTED ON (B)(6) 2023.

  Patient problems: Insufficient Information

  MAUDE report 20181769 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K152431, K212742. One submission often covers many models, so check the product and lot details in each record.

• 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
• Z-1554-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 55 MM Item Number: 15-2230/15
• Z-1551-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 55 MM Item Number: 15-2230/12
• Z-1545-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 45 MM Item Number: 15-2230/04
• Z-1543-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 45 MM Item Number: 15-2230/02
• Z-1550-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 55 MM Item Number: 15-2230/11
• Z-1542-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, LARGE Item Number: 15-2220/60
• Z-1548-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 13 MM X 50 MM Item Number: 15-2230/08
• Z-1549-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 55 MM Item Number: 15-2230/10
• Z-1541-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM Item Number: 15-2220/52
• Z-1539-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, SMALL Item Number: 15-2220/40
• Z-1544-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 11 MM X 45 MM Item Number: 15-2230/03
• Z-1540-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO SLED KNEE FEM COMP, MEDIUM SMALL Item Number: 15-2220/46
• Z-1546-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 9 MM X 50 MM Item Number: 15-2230/06
• Z-1553-2023 · Mar 21, 2023 · Open, Classified
  LINK SLED Knee System POREX ENDO MODEL SLED TIBIAL COMP 8 MM X 50 MM Item Number: 15-2230/14

…and 5 more.