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Terminated

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

FDA Recall Z-0170-06 · Posted 2005-11-18

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeHWC
Date Initiated2005-10-04
Date Terminated2006-05-04
Product Quantity34,839 units

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.

Firm Action

The product recall will extend to all branches.agencies and hospitals that have received the product.

Root Cause

Other

Distribution Pattern

nationwide

Official Source

View FDA Recall →

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

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