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Terminated

Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL 400; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ 07430. Intended to determine proper anatomical orientation, selection, alignment and position of the acetabular and femoral components.

FDA Recall Z-1915-2009 · Posted 2009-08-26

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeIQO
Date Initiated2007-09-11
Date Terminated2009-10-15
Product Quantity615

Reason for Recall

The bubble in a vial of the Pelvic Alignment Level (PAL) was wider than the level marking. Upon opening the PAL and removing the vial, it was discovered that the vial was leaking

Firm Action

Stryker Orthopaedics issued an "Important Product Removal" letter dated September 11, 2007 via Federal Express informing consignees of the affected devices. The firm requested that users identify and return any affected product and account for product by returning a Product Accountability Form via fax. For further information, contact Stryker Orthopaedics at 1-201-831-5825.

Root Cause

Device Design

Distribution Pattern

Nationwide Distribution

Official Source

View FDA Recall →

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

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