Porous titanium flared rim acetabular shell with three clustered holes in even sizes from 48 to 66mm, a hip prosthesis c
FDA device recall Z-0799-06 · posted 2006-04-27 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- Reason for recall
- Voids in the porous coating of a component used in total hip replacement surgery.
- Action taken
- Firm notified all sales agents by letter on January 12, 2006 with instructions to return the product. The second letters went out on January 30, 2006 to the sales associates with instructions to contact the implanting physicians.
- Root cause
- Other
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- Total of 30 units
- Distribution
- Nationwide. Iowa, Florida, California, Arizona, South Dakota, Utah, Missouri, Texas, and Massachusetts, Maryland, Oklahoma, Nevada
- Date initiated
- 2006-01-12
- Date posted
- 2006-04-27
- Date terminated
- 2006-07-11
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| METAL BACKED ACETABULAR COMPONENT (K950542) | Encore Orthopedics, Inc. | 1995-05-25 |