Encompass Hip Stem, Plasma Spray, 12/14 Taper, Extended, REF 109-XXXX, Sterile R, Ortho Development, Draper, Utah 84020.
FDA device recall Z-2603-2011 · posted 2011-06-20 · Terminated
Recall details
- Recalling firm
- Ortho Development Corporation
- Reason for recall
- Tests on PVC packaging material resulted in alert levels for cytotoxicity.
- Action taken
- Ortho Development Corporation notified consignees by letter on May 11, 2011. The letter identified the product, the problem, and the action to be taken by the consignee. Consignees were instructed to return all remaining affected units to Ortho. Replacement product was to be shipped by May 31.
- Root cause
- Package design/selection
- Status
- Terminated
- Product code
- MBL
- Quantity affected
- 113 units
- Distribution
- Nationwide Distribution - USA including CA, FL, and TX.
- Date initiated
- 2011-05-10
- Date posted
- 2011-06-20
- Date terminated
- 2011-11-09
- Location
- Draper, UT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENCOMPASS 10*17 AND 12*17 EXTENDED PRESS-FIT HIP STEMS (K053293) | Ortho Development Corp. | 2006-02-16 |