Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 46 mm dia. articular surface, large, ste
FDA device recall Z-0028-06 · posted 2005-10-07 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.
- Action taken
- Consignees were notified via letter dated August 23, 2005 or by email.
- Root cause
- Other
- Status
- Terminated
- Product code
- KWS
- Distribution
- Nationwide, Australia, Canada, England, Germany and Italy.
- Date initiated
- 2005-08-23
- Date posted
- 2005-10-07
- Date terminated
- 2005-12-08
- 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 |
|---|---|---|
| MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION (K031449) | Implex Corp. | 2003-09-23 |
| THE TRABECULAR METAL GLENOID-BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION, MODEL 4306 (K022377) | Implex Corp. | 2002-12-10 |