Device recall
Z-0824-2009: Tornier AFFINITI Humeral Head Eccentric 56mm x 21mm, Catalog No. 0020038…
FDA device recall · Class II · Tournier, Inc.
Key facts
| Recall number (Z-number) | Z-0824-2009 |
|---|---|
| Recall event | 50232 |
| Product | Tornier AFFINITI Humeral Head Eccentric 56mm x 21mm, Catalog No. 0020038. 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… |
| Product code | KWS |
| Recalling firm | Tournier, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 7, 2011 |
| 510(k) numbers | K060988 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database