Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell com
FDA device recall Z-0415-2013 · posted 2012-11-21 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The color code on label conflicts with the liner size (liner size 24 should be green, not yellow)
- Action taken
- BIOMET called distributors who received the affected product to return it to Biomet with follow-up Urgent Recall Notices sent via E-mail October 22, 2012.. The notice included the identity of the recalled device, reason for the recall, and directions to complete the FAX back form and return it to 574-372-1683. Product is to be returned to Return Goods, Recalls, Biomet, Inc. 56 East Bell Drive, Warsaw, IN 46580. Questions related to the recall should be directed to Field Action Coordinator (574) 372-1570, Monday through Friday. 8 a.m. to 5 p.m. For questions regarding this recall call 574-267-6639, ext 1676.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- KWA
- Quantity affected
- 16 (5 USA)
- Distribution
- Nationwide Distribution including CA, IN, NC, OH, and UT.
- Date initiated
- 2012-10-04
- Date posted
- 2012-11-21
- Date terminated
- 2013-03-18
- Location
- Warsaw, IN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| POROUS COATED ACETABULAR COMPONENTS (K050124) | Biomet, Inc. | 2005-10-04 |