Recall Z-0834-2009 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Tournier, Inc.
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 we
| Date | Jan 23, 2009 (initiated Oct 20, 2008) |
| Status | Terminated |
| Reason | 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 | 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 Tor |
| Quantity | 401 total |
| Distribution | AR, CA, FL, NC, NE, OH, PA, TN, TX, WA, and WI |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.