Z-0170-06

Gamma System, Cross Screw, Self-Tapping (Cleared under Grosse and Kempf Locking Nail System)

Name: Z-0170-06 Gamma System, Cross Screw, Self-Tapping (Cleared under Grosse and Kempf Locking Nail System)
Creator: Stryker Howmedica Osteonics Corp.
Published: 2005-10-04
License: https://open.fda.gov/license/

Howmedica Osteonics Corp / initiated 2005-10-04 / Terminated / root cause: packaging

FDA source

Stryker Howmedica Osteonics Corp. began a recall of Gamma System, Cross Screw, Self-Tapping (Cleared under Grosse and Kempf Locking Nail System) on 2005-10-04. The reason FDA records is "Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling...". 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-0170-06
Status: Terminated
Initiated: 2005-10-04
Posted: 2005-11-18
Terminated: 2006-05-04
Recalling firm: Howmedica Osteonics Corp
Product: Gamma System, Cross Screw, Self-Tapping (Cleared under Grosse and Kempf Locking Nail System)
Product code: HWC Screw, Fixation, Bone
Reason for recall: Stryker Orthopaedics was informed by the manufacturer, that in some instances, the sterile blister package of the referenced G/K, T2 condyle and some S2 screw products may become damaged during shipping and handling which may result in a potential breach of the sterile barrier.
Root cause tag: packaging
FDA root cause: Other
Action: The product recall will extend to all branches.agencies and hospitals that have received the product.
Quantity in commerce: 34,839 units
Distribution: nationwide
Product codes and lots: Catalog No 3370-5-035 to 3370-5-090

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)