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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.

FDA Recall Z-0974-2009 · Posted 2009-02-06

Recalling FirmZimmer Inc.
Recall StatusTerminated
Product CodeLYC
Date Initiated2009-01-22
Date Terminated2009-10-23
Product Quantity225 kits

Reason for Recall

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

Firm 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.

Root Cause

Packaging process control

Distribution Pattern

International Distribution including the country of Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K811101HYDROXYLAPATITECarbomedics, Inc. · 1981-11-20

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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