Recall Z-0974-2009 ยท LYC Bone Grafting Material, Synthetic
Zimmer Inc.
Zimmer Dental Calcitite 4060-2 Dense Nonresorbable Hydroxylapatite Bone Grafting Material, 4 ampules, 0.5g each, 40-60 mesh size, sterile. Zimmer Dental, Carlsbad, CA; Item # 0003. Device is used for filling of periodontal defects following conventional curettage and debridement. The device is also indicated for the esthetic repair of bony defects of the alveolar ridge beneath new or existing f
| Date | Feb 6, 2009 (initiated Jan 22, 2009) |
| Status | Terminated |
| Reason | Fragments of the glass vial may be present in some of the packages from these lots. |
| Root cause | Packaging process control |
| Action | 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. |
| Quantity | 225 kits |
| Distribution | International Distribution including the country of Japan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K811101 | HYDROXYLAPATITE Carbomedics, Inc., Nov 20, 1981 |