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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/
Manufacturer		 Whiteside Biomechanics
1000 Des Peres Road
Suite 140
St. Louis MO 63131
For Additional Information Contact Jerry Steiger
314-775-0518
Manufacturer Reason
for Recall		 The soft tissue pin in the retractor can break off and become embedded in the tissue.
FDA Determined
Cause 2		 Other
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.
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