ORTHOPEDIC SALVAGE SYSTEM (OSS) CP111827Recalls & reported problems

Biomet Orthopedics, LLC · Class 2 · Implant

All models of ORTHOPEDIC SALVAGE SYSTEM (OSS) (8)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports: 0
Deaths reported: 0
Injuries reported: 0
Recalls naming it: 1

Summary

No MAUDE adverse event reports in our data reference this device identifier directly.

1 FDA recall record name this device's identifier.

8 other recalls cover devices cleared under the same FDA submission (K020381, K043547); 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

Aug 21, 2019Class IITerminated
Elevated levels of bacterial endotoxin and residual debris remain on the devices due to cleaning issue.
Z-0526-2020 · Root cause: Environmental control · Recall details · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K020381, K043547. One submission often covers many models, so check the product and lot details in each record.

Z-0305-2018 · Jun 5, 2017 · Terminated
RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828
Z-0304-2018 · Jun 5, 2017 · Terminated
RED SEXP DSTL FEM 19CM RT ASSY, model # CP111817
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-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-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-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-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

Device details

UDI-DI	`00880304035300`
Brand	ORTHOPEDIC SALVAGE SYSTEM (OSS)
Model	CP111827
Company	Biomet Orthopedics, LLC
Product code	KWY · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Class	Class 2
FDA submission	K020381, K043547
Implant	Yes
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	Labeling does not contain MRI Safety Information
Status	In Commercial Distribution
Record updated	May 30, 2025

Device type (GMDN): Uncoated knee femur prosthesis, metallic

An implantable device designed to replace the femoral condyles (femoral component) during primary bicondylar replacement of the knee joint, femoral bone resection, or to replace a dysfunctional knee prosthesis (revision); it is made of metal [e.g., cobalt-chrome (Co-Cr), cobalt-chrome-molybdenum (Co-Cr-Mo), titanium (Ti)] and is not coated with a material intended to improve fixation and stability by promoting bone ingrowth. The device is designed to articulate with tibial and, if required, patellar prosthetic components of the knee joint and its implantation is intended to be performed with bone cement.

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2 recalls0 reports
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84 reports
LFIT 6260-9-036
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RINGLOC BI-POLAR HIP SYSTEM 11-165228
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1 recall1 death12 reports
SELF CENTERING 1035-44-000
Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
60 reports
TANDEM 71324046
Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
1 recall9 reports
TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170
Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
59 reports

All Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices →

Sources and updates

Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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