Z-1346-06

Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia., 35 mm length, tivanium TI-6AL-4V...

Name: Z-1346-06 Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia., 35 mm length, tivanium TI-6AL-4V...
Creator: Zimmer Inc.
Published: 2006-06-26
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2006-06-26 / Terminated / root cause: packaging

FDA source

Zimmer Inc. began a recall of Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia., 35 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-35 (00662406535) on 2006-06-26. The reason FDA records is "Lack of assurance of sterility, as the sterile barrier packaging may have been compromised". 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-1346-06
Status: Terminated
Initiated: 2006-06-26
Posted: 2006-08-03
Terminated: 2007-12-05
Recalling firm: Zimmer GmbH
Product: Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia., 35 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-35 (00662406535).
Product code: HWC Screw, Fixation, Bone
Reason for recall: Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.
Root cause tag: packaging
FDA root cause: Other
Action: Hospital accounts were notified via recall letter dated 6/26/06 and distributor accounts were notified via recall letter dated 6/28/06 to return the product. Recall was extended to additional lots via recall letter dated 7/26/06.
Quantity in commerce: 310 total for all catalog numbers
Distribution: Worldwide, including USA, Argentina, Brazil, Canada, China, England, France, Germany, Guatemala, Israel, Japan, Jordan, Lebanon, Poland, Saudi Arabia, Singapore, Spain, Taiwan, UAE.
Product codes and lots: Lots 12662700, 12718800, 12718900, 12757600, 12808600, 13331900, 13776600, 13776700, 13935600, 14196100, 14238900, 15590000, 15590100, 15610700, 16419200, 16579200, 16718400, 16718500, 16718600, 43764000, 48387800, 49078400, 49539800, 51295600, 52044900, 57690600, 57690800, 58905500, 59114400, 59476000, 66527800, 66527900, 66816800, 68890400, 68890500, 68890600 and 69606300.

Product code HWC

The FDA recall record names no cleared device, and no clearance has been matched to it.

China's FDA-registered implant bench is 151 establishments of 4,70415 SEP 2026 / by Medical Device Manufacturing

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)