Stryker Orthopaedics PAL Pelvic Alignment Level, Ref: PAL 400; Howmedica Osteonics Corp, 325 Corporate Drive, Mahwah, NJ
FDA device recall Z-1915-2009 · posted 2009-08-26 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- 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
- Action taken
- 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
- Status
- Terminated
- Product code
- IQO
- Quantity affected
- 615
- Distribution
- Nationwide Distribution
- Date initiated
- 2007-09-11
- Date posted
- 2009-08-26
- Date terminated
- 2009-10-15
- Location
- Mahwah, NJ
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