Tornier AFFINITI Humeral Head Standard 44mm x 15mm, Catalog No. 0020044. Sterile. Manufactured for Tornier, 10750 Cash R
FDA device recall Z-0825-2009 · posted 2009-01-23 · Terminated
Recall details
- Recalling firm
- Tournier, Inc.
- 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.
- Action taken
- 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.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- KWS
- Quantity affected
- 401 total
- Distribution
- AR, CA, FL, NC, NE, OH, PA, TN, TX, WA, and WI
- Date initiated
- 2008-10-20
- Date posted
- 2009-01-23
- Date terminated
- 2011-05-07
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| TOTAL AND HEMI SHOULDER SYSTEM (K060988) | Dvo Extremity Solutions, LLC | 2006-12-06 |