StageOne Select 431193Recalls & reported problems

Data updated Oct 13, 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.

14 other recalls cover devices cleared under the same FDA submission (K080979, K161166, K222760); 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

Feb 26, 2020Terminated
Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.
Z-1646-2020 · Root cause: Process control · FDA record ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K080979, K161166, K222760. One submission often covers many models, so check the product and lot details in each record.

Z-1648-2020 · Feb 26, 2020 · Terminated
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 200 MM, Silicone, Sterile, Item 431195.
Z-1640-2020 · Feb 26, 2020 · Terminated
BIOMET StageOne Hip Cement Spacer Mold with Insert, 56 MM, Silicone, Sterile, Item 431183.
Z-1649-2020 · Feb 26, 2020 · Terminated
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 200 MM, Silicone, Sterile, Item 431196.
Z-1650-2020 · Feb 26, 2020 · Terminated
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 200 MM, Silicone, Sterile, Item 431197.
Z-1651-2020 · Feb 26, 2020 · Terminated
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 15 X 200 MM, Silicone, Sterile, Item 431198.
Z-1647-2020 · Feb 26, 2020 · Terminated
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 165 MM, Silicone, Sterile, Item 431194.
Z-1642-2020 · Feb 26, 2020 · Terminated
BIOMET StageOne Hip Cement Spacer Mold with Insert, 64 MM, Silicone, Sterile, Item 431185.
Z-1639-2020 · Feb 26, 2020 · Terminated
BIOMET StageOne Hip Cement Spacer Mold with Insert, 52 MM, Silicone, Sterile, Item 431182.
Z-1641-2020 · Feb 26, 2020 · Terminated
BIOMET StageOne Hip Cement Spacer Mold with Insert, 60 MM, Silicone, Sterile, Item 431184.
Z-1652-2020 · Feb 26, 2020 · Terminated
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 17 X 200 MM, Silicone, Sterile, Item 431199.
Z-1645-2020 · Feb 26, 2020 · Terminated
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 13 X 145 MM, Silicone, Sterile, Item 431192.
Z-1644-2020 · Feb 26, 2020 · Terminated
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 11 X 135 MM, Silicone, Sterile, Item 431191.
Z-1643-2020 · Feb 26, 2020 · Terminated
BIOMET StageOne Select, Hip Stem Cement Spacer Mold w/Reinforcement Cement, 9 X 125 MM, Silicone, Sterile, Item 431190.
Z-1638-2020 · Feb 26, 2020 · Terminated
BIOMET StageOne Hip Cement Spacer Mold with Insert, 48 MM, Silicone, Sterile, Item 431181.

Device details

UDI-DI	`00880304521179`
Brand	StageOne Select
Model	431193
Company	Biomet Orthopedics, LLC
Product code	KWY · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
Class	Class 2
FDA submission	K080979, K161166, K222760
Implant	No
Rx / OTC	Prescription
Single use	Yes
Sterile	Yes
MRI safety	MR Unsafe
Status	In Commercial Distribution
Record updated	May 30, 2025

Device type (GMDN): Orthopaedic cement spacer mould

A moulding device designed to form an implantable provisional joint prosthesis component out of orthopaedic cement (otherwise known as a cement spacer), which is used in two-stage joint revision typically to treat joint arthroplasty infection. It is filled with prepared antibiotic-containing bone cement which cures into the shape of the prosthesis and is subsequently placed into the joint space until replaced with a revision joint prosthesis. It is typically made of silicone and available in a variety of shapes and sizes for different joint applications. This is a single-use device.

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

STAGEONE 431209
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2 recalls0 reports
SELF CENTERING 1035-45-000
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84 reports
LFIT 6260-9-036
Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
80 reports
ACTIS 101011060
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66 reports
RINGLOC BI-POLAR HIP SYSTEM 11-165228
Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
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
Compress® Device 178552
Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented
1 recall9 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 13, 2026
Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026 · each recall links to the FDA recall notice
Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.

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