Recall Z-0974-2009
Zimmer Inc. · initiated January 22, 2009
Product
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.
Codes / lots: Lots 60864773, 60879983 and 60967942.
Reason for recall
Fragments of the glass vial may be present in some of the packages from these lots.
FDA-determined cause: Packaging process control
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.
Details
- Recall number
- Z-0974-2009
- Initiated
- January 22, 2009
- Posted by FDA
- February 6, 2009
- Terminated
- October 23, 2009
- Product code
- LYC – Bone Grafting Material, Synthetic
- Quantity
- 225 kits
- Distribution
- International Distribution including the country of Japan.
- Recalling firm
- Zimmer Inc., Warsaw, IN