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Terminated

Gamma Drill 5.5x300mm

FDA Recall Z-0579-03 · Posted 2003-02-26

Recalling FirmStryker Howmedica Osteonics
Recall StatusTerminated
Product CodeHTW
Date Initiated2003-01-20
Date Terminated2003-05-06
Product Quantity5062

Reason for Recall

Certain sterile packed drills with center tip may penetrate the foam and blister resulting in loss of sterility.

Firm 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.

Root Cause

Other

Distribution Pattern

Product was distributed to 53 Howmedica Branches/agents, 996 hospitals, and 63 government hospitals throughout the nation.

Official Source

View FDA Recall →

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

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