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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker Orthopaedics PAL Pelvic Alignment Level

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  Class 2 Device Recall Stryker Orthopaedics PAL Pelvic Alignment Level see related information
Date Initiated by Firm September 11, 2007
Date Posted August 26, 2009
Recall Status1 Terminated 3 on October 15, 2009
Recall Number Z-1915-2009
Recall Event ID 52676
Product Classification Device, prosthesis alignment - Product Code IQO
Product 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.
Code Information Lot Numbers: 969A01, 969A02, 969A03, 969A04, 969A05, 968B01, 968B02, 100126171-01 and samples.
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Drive
Mahwah NJ 07430
For Additional Information Contact Colleen O'Meara
201-831-5970
Manufacturer 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
FDA Determined
Cause 2		 Device Design
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.
Quantity in Commerce 615
Distribution Nationwide Distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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