Stanmore modular hip system; Stanmore CoCr femoral size 1 straight stem; part 164251
FDA device recall Z-1286-03 · posted 2003-09-24 · Terminated
Recall details
- Recalling firm
- Biomet, Inc.
- Reason for recall
- The labeling does not instruct the removal of the protective shipping cap, and one surgeon implanted with the cap still in place.
- Action taken
- Distributors were sent a letter on June 18, 2003 via FedEx. This mailing contained labels and the distributors were instructed to affix the label to the inventory consigned to hospitals within their territory.
- Root cause
- Other
- Status
- Terminated
- Product code
- JDI
- Quantity affected
- 28
- Distribution
- United States
- Date initiated
- 2003-06-18
- Date posted
- 2003-09-24
- Date terminated
- 2003-09-23
- 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 |
|---|---|---|
| BIOMET COBALT-CHROME FEMORAL COMPONENTS (K911684) | Biomet, Inc. | 1991-06-27 |