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U.S. Department of Health and Human Services

Class 2 Device Recall Posterior Acetabular Retractor with Light Cord Bracket

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  Class 2 Device Recall Posterior Acetabular Retractor with Light Cord Bracket see related information
Date Initiated by Firm September 15, 2006
Date Posted December 27, 2006
Recall Status1 Terminated 3 on June 11, 2008
Recall Number Z-0316-2007
Recall Event ID 36760
Product Classification surgical retractor - Product Code GAD
Product Posterior Acetabular Retractor-Left with Light Cord Bracket, Model #BIO-1-1050-A, and Posterior Acetabular Retractor-Right with Light Cord Bracket, Model #BIO-1-1051-A, packaged 1 retractor (left or right retractor) per plastic bag. The firm name on the label is Whiteside Biomechanics, Inc., St. Louis, MO.
Code Information Lot #P0835-1
Recalling Firm/
Whiteside Biomechanics
1000 Des Peres Road
Suite 140
St. Louis MO 63131
For Additional Information Contact Jerry Steiger
Manufacturer Reason
for Recall
The soft tissue pin in the retractor can break off and become embedded in the tissue.
FDA Determined
Cause 2
Action The recalling firm was notified of the problem via a telephone call from the surgeon on 9/15/06 and the remaining retractors were placed in quarantine by the hospital. The recalling firm requested return of the retractors. The recalling firm immediately visited the one remaining hospital on 9/15/06 and picked up their inventory of six retractors.
Quantity in Commerce 10 retractors (5 right, 5 left)
Distribution Distribution was made to two hospitals, one in MD and the other in MO.
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.