Z-0819-2009

Tornier AFFINITI Humeral Stem Standard 14mm, Catalog No. 0020014. Sterile. Manufactured for Tornier, 10750...

Name: Z-0819-2009 Tornier AFFINITI Humeral Stem Standard 14mm, Catalog No. 0020014. Sterile. Manufactured for Tornier, 10750...
Creator: Tournier, Inc.
Published: 2008-10-20
License: https://open.fda.gov/license/

Tournier, Inc. / initiated 2008-10-20 / Terminated / root cause: labeling and UDI

FDA source

Tournier, Inc. began a recall of Tornier AFFINITI Humeral Stem Standard 14mm, Catalog No. 0020014. Sterile. Manufactured for Tornier, 10750 Cash Rd., Stafford, TX 77477. Tornier's Affiniti... on 2008-10-20. The reason FDA records is "Tornier, Medical has received a 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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0819-2009
Status: Terminated
Initiated: 2008-10-20
Posted: 2009-01-23
Terminated: 2011-05-07
Recalling firm: Tournier, Inc.
Product: 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.
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Reason for recall: Tornier, Medical has received a 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 tag: labeling and UDI
FDA 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 in commerce: 401 total
Distribution: AR, CA, FL, NC, NE, OH, PA, TN, TX, WA, and WI
Product codes and lots: Lot No.: AA1434

Product code KWS

K060988Class IITotal and Hemi Shoulder SystemDvo Extremity Solutions, LLC / cleared 2006-12-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)