—#77599

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.

FDA product code: LYC — Bone Grafting Material, Synthetic
Device class: Class 2
Medical specialty: Dental
510(k) numbers: K811101
Affected lot / code info: Lots 60864773, 60879983 and 60967942.

Why it was recalled

Fragments of the glass vial may be present in some of the packages from these lots.

Root cause (FDA determination)

Packaging process control

Action the firm took

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.

Recalling firm

Firm: Zimmer Inc.
Address: 345 E Main St, Warsaw, Indiana 46580-2746

Distribution

Distribution pattern: International Distribution including the country of Japan.

Timeline

Recall initiated: 2009-01-22
Posted by FDA: 2009-02-06
Terminated: 2009-10-23
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #77599. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.