Zimmer Dental Calcitite 4060-2 Dense Nonresorbable Hydroxylapatite Bone Grafting Material, 4 ampules, 0.5g each, 40-60 m
FDA device recall Z-0974-2009 · posted 2009-02-06 · Terminated
Recall details
- Recalling firm
- Zimmer Inc.
- Reason for recall
- Fragments of the glass vial may be present in some of the packages from these lots.
- Action taken
- The consignee in Japan was notified by e-mail and "Urgent: Device Recall" letter dated January 22, 2009 to stop using the product and to return it to the firm.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- LYC
- Quantity affected
- 225 kits
- Distribution
- International Distribution including the country of Japan.
- Date initiated
- 2009-01-22
- Date posted
- 2009-02-06
- Date terminated
- 2009-10-23
- 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 |
|---|---|---|
| HYDROXYLAPATITE (K811101) | Carbomedics, Inc. | 1981-11-20 |