FDA Medical Device Recalls (openFDA)
Tournier, Inc.: Tornier AFFINITI Humeral Head Standard 48mm x 21mm, Catalog No. 0020050. 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.
- Recall number
- Z-0830-2009
- Recalling firm
- Tournier, Inc.
- Product
- Tornier AFFINITI Humeral Head Standard 48mm x 21mm, Catalog No. 0020050. 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.
- Status
- Terminated
- Initiated
- 2008-10-20
- Posted
- 2009-01-23
- Terminated
- 2011-05-07
- Reason
- Tornier, Medical has received on report of a mislabeled sterile AFFINITI head product. As a result, Tornier has decided to voluntarily recall the potentially affected lots, including two (2) lots of AFFINITI Stems.
- Root cause
- Labeling Change Control
- Action
- An Urgent Product Recall letter, dated 10/17/08, was hand delivered to end users by distributors and sales representatives beginning 10/20/08. The recall letter identified the issue and requested end users to immediately discontinue use of the affected products and return any unused affected products to Tornier. Distributors were to notify any and all accounts that may be end users or to provide this information to Tornier, whom will contact the end users. A questionnaire and return instructions were provided with the letter. The questionnaire was asked to be completed and returned to Tornier as soon as possible. For additional information, contact Tornier Customer Service at 1-888-494-7950.
- Quantity
- 401 total
- Distribution
- AR, CA, FL, NC, NE, OH, PA, TN, TX, WA, and WI
- Lot, serial or model codes
- Lot No.: AA1293
- 510(k) numbers
- ["K060988"]
- PMA numbers
- not on file
- Product code
- KWS
- Firm FEI
- not on file
- Firm city
- not on file
- Firm state
- not on file
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28