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 fixed prosthetic restorations. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Zimmer Inc.
Lot Codes / Batch Numbers
Lots 60864773, 60879983 and 60967942.
Products Sold
Lots 60864773, 60879983 and 60967942.
Zimmer Inc. is recalling Zimmer Dental Calcitite 4060-2 Dense Nonresorbable Hydroxylapatite Bone Grafting Material, 4 ampules due to Fragments of the glass vial may be present in some of the packages from these lots.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Fragments of the glass vial may be present in some of the packages from these lots.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026