Tournier, Inc.

Lot No.: AA1208, and AA1442

Orthopedic Devices

2

Yes

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

Tornier AFFINITI Humeral Head Standard 56mm x 21mm, Catalog No. 0020058. 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.: AA1298

Orthopedic Devices

2

Yes

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

Tornier AFFINITI Humeral Head Standard 56mm x 21mm, Catalog No. 0020057. 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.: AA1440

Orthopedic Devices

2

Yes

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

Tornier AFFINITI Humeral Head Standard 52mm x 21mm, Catalog No. 0020054. 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.: AA1295, and AA1439

Orthopedic Devices

2

Yes

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

Tornier AFFINITI Humeral Head Standard 52mm x 18mm, Catalog No. 0020053. 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.: AA1294

Orthopedic Devices

2

Yes

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

Tornier AFFINITI Humeral Head Standard 52mm x 15mm, Catalog No. 0020052. 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.