OSS™ Orthopedic Salvage System 150414Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00880304006492), received between Apr 23, 2021 and Apr 2, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 FDA recall record name this device's identifier.

13 other recalls cover devices cleared under the same FDA submission (K002757); 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. Apr 17, 2020Class IITerminated

   Potential presence of elevated endotoxin levels that exceed the specification limit

   Z-2147-2020 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY REVISION TO ADDRESS IMPLANT FRACTURE OF THE TIBIAL BEARING AFTER A FALL APPROXIMATELY FIFTEEN (15) MONTHS POST-OPERATIVELY. ATTEMPTS HAVE MADE, HOWEVER, NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: Failure of Implant

  MAUDE report 21754498 ↗
• MalfunctionNov 15, 2021Tear, Rip or Hole in Device Packaging; Packaging Problem; Tear, Rip or Hole in Device Packaging; Packaging Problem

  SEE H10 NARRATIVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12811429 ↗
• InjuryApr 23, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT WAS REVISED APPROXIMATELY TWO MONTHS¿ POST IMPLANTATION DUE TO WOUND HEALING PROBLEMS THAT DISENGAGED HIS HINGED FEMUR FROM HIS RIGHT TIBIAL COMPONENT. THIS WAS A RESULT OF HAVING HAD A DISTAL FEMORAL REPLACEMENT WITH ABSENCE OF COLLATERAL LIGAMENTS CAUSING THE FEMUR TO DISENGAGE FROM THE TIBIA WHEN THE KNEE BECAME FLEXED. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN MADE; HOWEVER, NO MORE INFORMATION IS AVAILABLE.

  Patient problems: Damage to Ligament(s); Impaired Healing; Pain

  MAUDE report 11716192 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K002757. One submission often covers many models, so check the product and lot details in each record.

• Z-0623-2021 · Nov 25, 2020 · Terminated
  OSS Polyethylene Tibial Bushing, Item number 150476 - Product Usage: intended for use in limb salvage.
• Z-0590-2019 · Oct 10, 2018 · Terminated
  Orthopedic Salvage System (OSS) Porous Stem, Item No. 150394
• Z-0303-2018 · Jun 5, 2017 · Terminated
  OSS CEMENTED IM STEM 12X150, model # 150366
• Z-0417-2012 · Nov 1, 2011 · Terminated
  OSS INTERLOK BOWED IM STEM W/SCREW 14 MM X 150 MM TI 6AL 4V ALLOY. Hip and knee joint replacement prostheses intended for primary and revision joint arthroplasty for use in cement
• Z-1527-2009 · May 19, 2009 · Terminated
  Biomet OSS FINN Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472087. A non-powered, orthopedic manual surgical instrum
• Z-1530-2009 · May 19, 2009 · Terminated
  Biomet OSS Elliptical Proximal Femoral Trial 7 cm, right provisional, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472124. A non-powered, orthopedic manual surgic
• Z-1528-2009 · May 19, 2009 · Terminated
  Biomet OSS Letson Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472088. A non-powered, orthopedic manual surgical inst
• Z-1531-2009 · May 19, 2009 · Terminated
  Biomet OSS Elliptical Proximal Femoral Trial 7 cm left provisional, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472125. A non-powered, orthopedic manual surgical
• Z-1526-2009 · May 19, 2009 · Terminated
  Biomet OSS FINN Proximal Femoral Trial 7 cm resection/right, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472086. A non-powered, orthopedic manual surgical instru
• Z-1529-2009 · May 19, 2009 · Terminated
  Biomet OSS Letson Proximal Femoral Trial 7 cm resection/left, stainless steel, Biomet Orthopedics, Inc., Warsaw, IN; REF 32-472089. A non-powered, orthopedic manual surgical instr
• Z-1880-2008 · May 15, 2008 · Terminated
  Biomet OSS Interlok IM Stem w/Screw, straight collar, 13 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150491. Orthopedic implant intended as part
• Z-1879-2008 · May 15, 2008 · Terminated
  Biomet OSS Interlok IM Stem w/Screw, straight collar, 11 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150490. Orthopedic implant intended as part
• Z-1881-2008 · May 15, 2008 · Terminated
  Biomet OSS Interlok IM Stem w/Screw, straight collar, 15 mm x 225 mm, TI6AL4V alloy, sterile, Biomet Orthopedics, Inc., Warsaw, IN; REF 150492. Orthopedic implant intended as part