Encore Medical, Lp: Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.

Agency Publication Date: November 6, 2017

Affected Products

Product: Cobalt HV Bone Cement 40GM, REF 402282, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joi

Lot Numbers: 508220, 189680, 199200, 310390, 424730, 668130, 668150, 871240, 959720

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Product: Cobalt MV Bone Cement 40GM, REF 402438, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporosis, secondary severe joi

Lot Numbers: 507830, 871270, 959670

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Product: Cobalt MV with Gentamicin, Cobalt Bone Cement 40GM, REF 402439, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporos

Lot Numbers: 508250, 959680

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Product: Cobalt HV with Gentamicin, Cobalt Bone Cement 40GM, REF 402283, QTY 1, STERILE, Rx Only, Mfgr: BIOMET ORTHOPEDICS Cobalt MV and HV Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee and other joints to fix plastic and metal prosthetic parts to living bone when reconstructions is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the neck of the femur, sickle cell anemia osteoporos

Lot Numbers: 189690, 189760, 199180, 424740, 508240, 560290, 595660, 638280, 786630, 959650, 959700

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Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 77801

Status: Active

Manufacturer: Encore Medical, Lp

Manufactured In: United States

Units Affected: 4 products (7143 units; 840 units; 1815 units; 9848 units)

Agency Last Updated: August 30, 2018

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Sources: FDA iRES · Raw API Response

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Affected Products

Lot Numbers: 508220, 189680, 199200, 310390, 424730, 668130, 668150, 871240, 959720

Lot Numbers:

Numbers

Lot Numbers: 507830, 871270, 959670

Lot Numbers:

Numbers

Lot Numbers: 508250, 959680

Lot Numbers:

Numbers

Lot Numbers: 189690, 189760, 199180, 424740, 508240, 560290, 595660, 638280, 786630, 959650, 959700

Lot Numbers:

Numbers