Z-0580-03

Gamma AO Drill 5.5x300mm

Name: Z-0580-03 Gamma AO Drill 5.5x300mm
Creator: Stryker Howmedica Osteonics
Published: 2003-01-20
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2003-01-20 / Terminated / root cause: packaging

FDA source

Stryker Howmedica Osteonics began a recall of Gamma AO Drill 5.5x300mm on 2003-01-20. The reason FDA records is "Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility". 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-0580-03
Status: Terminated
Initiated: 2003-01-20
Posted: 2003-02-26
Terminated: 2003-05-06
Recalling firm: Howmedica Osteonics Corp
Product: Gamma AO Drill 5.5x300mm
Product code: HTW Bit, Drill
Reason for recall: Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.
Root cause tag: packaging
FDA root cause: Other
Action: Howmedica sent notification letters and product accountability forms to all branches/agents via FedEx with return receipt. To Hospitals, notifications letters were sent to OR Supervisors via FedEx with return receipts.
Quantity in commerce: 53
Distribution: Product was distributed to 53 Howmedica Branches/agents, 996 hospitals, and 63 government hospitals throughout the nation.
Product codes and lots: 1212-5300S -- Gamma AO Drill 5.5x300mm-- K626400; K626401; K626402; K821823; K821824.

Product code HTW

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

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