Biomet Integral Centralizer Hip System, Lateralized Femoral Stem (Co-Cr-Mo), 9mm, 11mm, 13mm, 15mm, and 17mm
FDA device recall Z-0650-2016 · posted 2016-01-13 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- PMMA is listed as a material on the label but the product does not contain PMMA.
- Action taken
- On 11/17/2015, URGENT MEDICAL DEVICE RECALL NOTICE notifications were sent to the affected distributors via courier with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.
- Root cause
- Labeling Change Control
- Status
- Terminated
- Product code
- LZO
- Quantity affected
- 21
- Distribution
- Worldwide distribution. US nationwide including IA, UT, MN, PA, MO, OK, IL, OH, and WA; CANADA, and NETHERLANDS
- Date initiated
- 2015-11-17
- Date posted
- 2016-01-13
- Date terminated
- 2016-07-05
- 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 |
|---|---|---|
| INTEGRAL CO-CR FEMORAL COMPONENT (K942479) | Biomet, Inc. | 1994-09-20 |