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U.S. Department of Health and Human Services

Class 2 Device Recall Gliding Nail Radiolucent Guide instrument set

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  Class 2 Device Recall Gliding Nail Radiolucent Guide instrument set see related information
Date Initiated by Firm February 22, 2006
Date Posted June 02, 2006
Recall Status1 Terminated 3 on December 13, 2007
Recall Number Z-0928-06
Recall Event ID 35054
Product Classification Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component - Product Code KTT
Product Model Number: GNRADIOLUCENTGUIDE (Gliding Nail Radiolucent Guide), instrument set that contains one unit of each of the following instrument:
1130020-A: GNp Carbon Targeting Handle
1130021-A: GN Adapter Screw for Handle SW 10
1130022-A: GN Targeting Guide Carbon 125¿
1130023-A: GN Targeting Guide Carbon 135¿
1130060-A: GNp Drill Guide Locking No. 3
1133158-A: GN Centering Sleeve New Guide

Description: Surgical instruments comprising the Gliding Nail Radiolucent Guide, supplied unsterile for use in reusable sterilization trays.
Code Information Revision A Serial Number: None
Recalling Firm/
Manufacturer		 Plus Orthopedics USA
10188 Telesis Ct
San Diego CA 92121-4779
For Additional Information Contact Emmanuel Tribie
888-741-7587 Ext. 2513
Manufacturer Reason
for Recall		 PLUS USA has been informed by PLUS AG that the accuracy of the instrument set may be affected in some cases. It is possible that in rare cases where patients have sclerotic (excessively hardened or firm) bone, that components may deform under application of force as the surgeon attempts to penetrate this bone with the instruments.
FDA Determined
Cause 2		 Other
Action There were a total of five (5) radiolucent guide instrument sets affected by the recall (imported to the U.S. between 1/23/2006 and 1/30/2006). The firm telephoned agents beginning February 22, 2006, requesting return of the devices. Returned Material Authorizations have been issued (March, 2006) for consigned inventory in the field with instructions given to remove and return affected units immediately. All returns to PLUS Orthopedics USA have been appropriately quarantined and segregated to prevent unintended use or shipment.
Quantity in Commerce 5
Distribution There were a total of five (5) radiolucent guide instrument sets affected by the recall (imported to the U.S. between 1/23/2006 and 1/30/2006). The 5 sets were distributed in the following states: 1) California, 2) Idaho, and 3) New York.
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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