Zimmer, Insall/Burstein II Modular Knee System, Tibial Wedge and 2 Screws, Size 59, 7 Deg. x 9.5 mm Height, Tivanium TI-
FDA device recall Z-0555-2010 · posted 2009-12-22 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- Smaller diameter screws than required were included in the package.
- Action taken
- Zimmer notified consignees by recall letter dated 2/25/09 instructing them to cease use of the device and to return it. Zimmer distributors and international accounts were notified by email on 2/26/09.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HSX
- Quantity affected
- 13
- Distribution
- USA (Connecticut, Indiana, Pennsylvania), Australia, Serbia, Spain, Switzerland and the United Kingdom.
- Date initiated
- 2009-02-26
- Date posted
- 2009-12-22
- Date terminated
- 2011-02-28
- 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 |
|---|---|---|
| INSALL/BURSTEIN(TM)* II TIBIAL WEDGES (K862632) | Zimmer, Inc. | 1987-03-25 |