Mako Surgical Corporation

Part Item #: 204863 - THA 1.0 Application User Guide Part Item #: 207116 - THA 2.0 Application User Guide Part Item #: 208692 - THA 2.1 Application User Guide Part Item #: 209711 - MAKOplasty THA Application User Guide Part Item #: 210555 - MAKIplast THA 3.1 Application User Guide Part Item#: 212026 - THA Application User Guide 2.1-2.1.1 THA 3.0, THA 3.1, 3.1.1 and 3.1.1.1  Part Item # 204863 THA 1.0 Application User Guide Part Item # 207116 THA 2.0 Application User Guide Part Item # 208692 THA 2.1 Application User Guide Part Item # 209711 MAKOplasty THA Application User Guide Part Item # 210555 MAKIplast THA 3.1 Application User Guide Part Item # 212026 THA Application User Guide

Orthopedic Devices

2

No

US nationwide distribution.

MAKO RIO THA Application User Guides, for total hip arthroplasty, orthopedic surgery.

Lot No. 05212015

Orthopedic Devices

2

No

Distributed to the states of AZ, CA, CO, CT, FL, GA, ID, LA, MA, MO, MS, NC, OH, PA, TN, TX, & WA.

MAKO RIO Standard System, internal cPCI Card CageP/N: 201337. || Intended to assist the surgeon in providing software defined spatial boundaries during orthopedic procedures.

Size 2 Item # 180612 Lot # 26080317-01 and  Size 7 Item # 180617 Lot # 26150217-01.

Orthopedic Devices

2

No

AL, AR, AZ, CA, CO, FL, GA, ID, IL, IN, KS, LA, MA, MD, MI, MN, NC, NE, NH, NJ, NY, OK, OR, PA, RI, SC, TX, UT, VA, WA, WY, and Hawaii Australia, Italy, Netherlands, Singapore, South Korea, United Kingdom, and Vietnam

RESTORIS MCK TIBIAL BASEPLATE-RM/LL used in unicompartmental knee arthroplasty and knee replacements.

Item No. 160430, Lot No. 19020414, 19090616, 19090915, 19100616, 19100915, 19110317, 19110616, 19110915, 19130315, 19140315, 19451016, 19461016, 19471016, 19490515, 19500515, 19510515, 19520515, 19530515, 26051212, 26070512, 26080913, 26110512, 26120512, 26130512, 26170513, 26201111, 26290412, 26330712, 26340312, 26440912.

Orthopedic Devices

2

Yes

Distributed domestically to AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, MD, MI, MN, MO, NC, NE, NH, NJ, NV, NY, OH, OK, OR, PA, TN, TX, UT, WI. Distributed internationally to Australia, China, Italy, Netherlands, Singapore, South Africa, Taiwan, Turkey, United Kingdom.

Restoris MCK Onlay Insert Extractor.

All lots recalled, Catalog No. 207080.

Orthopedic Devices

2

No

Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, WV, & WY and the countries of Italy, Germany, Australia, China, Europe, Hong Kong, South Africa, Germany, Thailand & Singapore.

Stryker Restoris RIO Reamer Handle, Offset, Mako Rx only || Product Usage: || The handle is used to hold surgical components during acetabular reaming in MAKO Total Hip procedures.