FDA Recall
Terminated
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 fixed prosthetic restorations.
Recall: Z-0974-2009
·
Initiated January 22, 2009
Recall
- Recall Number
- Z-0974-2009
- Event Number
- 50887
- Firm
- Zimmer Inc.
- FEI Number
- 1000220733
- Product Code
- LYC
- Status
- Terminated
- Root Cause
- Packaging process control
- Initiated
- January 22, 2009
- Posted
- February 6, 2009
- Terminated
- October 23, 2009
- Address
- 345 E Main St, Warsaw, IN, 46580-2746
Description
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 fixed prosthetic restorations.
Reason
Fragments of the glass vial may be present in some of the packages from these lots.
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.
Distribution
International Distribution including the country of Japan.
Quantity
225 kits