FDA (Devices) recall action 65459

Biomet, Inc. recalled 30 products on 2013-07-17

The FDA (Devices) publishes a recall like this one as 30 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 30 pages.

Products: 30
Announced: 2013-07-17
Critical: 0
Units: 794

Why these products were recalled

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–25 of 30

HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw
Biomet is recalling 30 units of Oxford Fixed Bearing Partial Knee components because a design flaw may cause bone impingement.
Product
REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 28 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.
Product
REF 154202 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 26 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.
Product
REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing t
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 22 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause anterior impingement.
Product
REF 154201 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 25 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement between bone and the poly bearing.
Product
REF 154207 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw
Biomet is recalling 22 Oxford Fixed Bearing Partial Knee components because a design flaw may cause bone impingement during full knee extension.
Product
REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 26 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause anterior impingement.
Product
REF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing t
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 25 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.
Product
REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
SevereFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 22 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.
Product
REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 23 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.
Product
REF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 25 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.
Product
REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 31 units of Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.
Product
REF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 25 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.
Product
REF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Implants
Biomet is recalling 20 Oxford Fixed Bearing Partial Knee implants due to a design defect that may cause anterior impingement between bone and the poly bearing component.
Product
REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 46 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.
Product
REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Implants
Biomet is recalling 23 Oxford Fixed Bearing Partial Knee implants due to a design flaw that may cause bone impingement.
Product
REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw
Biomet is recalling 22 Oxford Fixed Bearing Partial Knee components because a design flaw creates a potential for anterior impingement between bone and the poly bearing.
Product
REF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size 6ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing ti
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 29 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.
Product
REF 154221 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 24 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.
Product
REF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 25 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.
Product
REF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components Due to Design Flaw
Biomet is recalling 23 Oxford Fixed Bearing Partial Knee components because the tibial bearing design may cause anterior impingement in terminal extension.
Product
REF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 24 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.
Product
REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 28 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause bone impingement.
Product
REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing t
Category
Distribution
4 states
HighFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 26 Oxford Fixed Bearing Partial Knee components due to a design flaw that may cause anterior impingement.
Product
REF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states
SevereFDA (Devices)··2013-07-17
Biomet Recalls Oxford Fixed Bearing Partial Knee Components
Biomet is recalling 30 Oxford Fixed Bearing Partial Knee components due to a design defect that may cause anterior impingement.
Product
REF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing
Category
Distribution
4 states