Z-0974-2009

Zimmer Dental Calcitite 4060-2 Dense Nonresorbable Hydroxylapatite Bone Grafting Material, 4 ampules, 0.5g...

Name: Z-0974-2009 Zimmer Dental Calcitite 4060-2 Dense Nonresorbable Hydroxylapatite Bone Grafting Material, 4 ampules, 0.5g...
Creator: Zimmer Inc.
Published: 2009-01-22
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2009-01-22 / Terminated / root cause: packaging

FDA source

Zimmer Inc. began a recall of Zimmer Dental Calcitite 4060-2 Dense Nonresorbable Hydroxylapatite Bone Grafting Material, 4 ampules, 0.5g each, 40-60 mesh size, sterile. Zimmer Dental... on 2009-01-22. The reason FDA records is "Fragments of the glass vial may be present in some of the packages from these lots". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0974-2009
Status: Terminated
Initiated: 2009-01-22
Posted: 2009-02-06
Terminated: 2009-10-23
Recalling firm: Zimmer GmbH
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.
Product code: LYC Bone Grafting Material, Synthetic
Reason for recall: Fragments of the glass vial may be present in some of the packages from these lots.
Root cause tag: packaging
FDA root cause: Packaging process control
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.
Quantity in commerce: 225 kits
Distribution: International Distribution including the country of Japan.
Product codes and lots: Lots 60864773, 60879983 and 60967942.

Product code LYC

K811101Class IIHydroxylapatiteCarbomedics, Inc. / cleared 1981-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)