Tournier, Inc.

Lot No.: AA1234

Orthopedic Devices

2

Yes

AR, CA, FL, NC, NE, OH, PA, TN, TX, WA, and WI

Tornier AFFINITI Humeral Stem Standard 10mm, Catalog No. 0020010. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.

Lot No.: AA1434

Orthopedic Devices

2

Yes

AR, CA, FL, NC, NE, OH, PA, TN, TX, WA, and WI

Tornier AFFINITI Humeral Stem Standard 14mm, Catalog No. 0020014. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.

Lot No.: AA1157C, and AA1435

Orthopedic Devices

2

Yes

AR, CA, FL, NC, NE, OH, PA, TN, TX, WA, and WI

Tornier AFFINITI Humeral Head Eccentric 44mm x 18mm, Catalog No. 0020025. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.

Lot No.: AA1158C, and AA1436

Orthopedic Devices

2

Yes

AR, CA, FL, NC, NE, OH, PA, TN, TX, WA, and WI

Tornier AFFINITI Humeral Head Eccentric 44mm x 21mm, Catalog No. 0020026. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.

Lot No.: AA1303

Orthopedic Devices

2

Yes

AR, CA, FL, NC, NE, OH, PA, TN, TX, WA, and WI

Tornier AFFINITI Humeral Head Eccentric 48mm x 21mm, Catalog No. 0020030. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti Shoulder System is a non-constrained glenohumeral prosthesis intended for use as a total or hemi-shoulder replacement system. The total shoulder consists of a metal humeral stem, a metal humeral head and an ultrahigh molecular weight polyethylene glenoid. The hemi-shoulder consists of a metal humeral stem and a metal humeral head.