Device Recall 3DKNEE

Lot # 292G1910

Orthopedic Devices

2

Yes

Worldwide Distribution-US (nationwide) to states of: AL, TX, UT, and CA; and countries of: INDIA and GERMANY.

3DKNEE(TM) SYSTEM e+, tibial Insert, LEFT Sz 6 / 11mm, REF 391-11-706, QTY 01, || The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.

Lot # 339G1045

Orthopedic Devices

2

Yes

Worldwide Distribution-US (nationwide) to states of: AL, TX, UT, and CA; and countries of: INDIA and GERMANY.

3DKNEE(TM) SYSTEM e+, Tibial Insert, RIGHT Sz 8 / 11mm, REF 391-11-708, QTY 01 || The 3DKnee Insert HXL Tibial Inserts are manufactured from ultra high molecular weight polyethylene (UHMWPE) infused with pure liquid pharmaceutical grade alpha-tocopheral and then cross-linked to conform to ASTM F2695. This insert is intended to more closely match the kinematics of the knee, allowing some rotation along the medial condyle and increased congruency along the lateral condyle.

Lot #434322.

Orthopedic Devices

2

Yes

Device distributed to direct accounts in AZ, CA, FL, GA, MO, NJ, OK, SC, SD and TX. Foreign consignies located in Freiburg and Langelsheim, Germany.

Size 8 right 3DKnee Non-porous Baseplates (Catalog #333-02-108) joint knee replacement.

Lot #53906407

Orthopedic Devices

2

Yes

Distribution --- country of Germany.

3DKNEE Tibial Insert Trial, Size 2, 13mm Right; Part #801-01-640; manufactured by Encore Medical, L.P., Austin, TX 78758. || Used in surgery to determine the correct size of 3DKnee component to implant that would allow for the best range of motion and joint stability.

Size 8, Left, Part # 333-01-108, Lot# A1000003

Orthopedic Devices

2

Yes

Florida, Missouri, and Italy

3DKnee Baseplates, Size 8, Left, Part # 333-01-108, Lot# A1000003.