Device Recall Advance

all codes

Orthopedic Devices

2

Yes

Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom

ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA60, SIZE 6 STD; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 6 FEMUR & SIZE 6 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

all codes

Orthopedic Devices

2

Yes

Worldwide Distribution only to Australia, Austria, France, Italy, Spain, and United Kingdom

ADVANCE(R) II MODULAR TIBIAL BASE W/SCREWHOLES, Knee Tibial Base, REF KTTIHA11, SIZE 1+; SURFACE POROUS, HA COATED; FIT CEMENTLESS; USE W/ SIZE 1 FEMUR & SIZE 1 TIBIAL INSERT; CONTENTS, 1 EACH, STERILE R, Rx ONLY, MicroPort Knee Systems Total Knee Systems MicroPort Total Knee Systems are indicated for use in knee arthroplasty in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

Lot Numbers: 17282012, 17283012, 17297012, 17298012  UDI: (01)4546540055415

Orthopedic Devices

1

No

Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.

Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 || for orthopedic use.

Product #04-CC900, Lot #40475C4144 and 40474C4148 *amend to include 40494C4154

Radiology Devices

2

No

Nationwide and Canada

Advance¿ Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile, Manufactured by Advance Medical Designs, Inc., 1241 Atlanta Industrial Drive, Marietta, GA 80066 USA.

Lot numbers 544531 to 544548 and 544502 to 544504.

Hematology and Pathology Devices

2

No

The product was shipped nationwide to medical facilities.

Advanced D-Dimer. Fibrinogen and fibrin split products Catalog numbers OQWM11 and OQEM13.