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U.S. Department of Health and Human Services

Class 2 Device Recall Bold/INIClip

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  Class 2 Device Recall Bold/INIClip see related information
Date Initiated by Firm November 10, 2006
Date Posted January 09, 2007
Recall Status1 Terminated 3 on April 16, 2008
Recall Number Z-0466-2007
Recall Event ID 36868
510(K)Number K990622  
Product Classification Drill Bit - Product Code HTW
Product BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment.
Code Information Model/Catalog number: 159004ND Lot Number: D2CJ/; D2CJ/1; D2PS; E0X4; E14K; E14L; E14M; E14N; E1KM; E1KN; E1X2; E24S; E2JS; E2LP.
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
311 Enterprise Dr
Plainsboro NJ 08536-3344
For Additional Information Contact Jon Caparotta
609-936-2495
Manufacturer Reason
for Recall		 Incorrect drill length-Cannulated drill bits were manufactured to incorrect specifications (shorter length) resulting in inadequate preparation of bone prior to insertion of the UNI-CLIP Staple.
FDA Determined
Cause 2		 Other
Action An Urgent Recall Notice was sent on 11/10/2006 to both hospitals/distributors and sales representatives by first class mail.
Quantity in Commerce 107 in US.
Distribution Nationwide to distributors, hospitals and Integra Sales Reps.
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.
510(K) Database 510(K)s with Product Code = HTW and Original Applicant = NEWDEAL S.A.
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