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U.S. Department of Health and Human Services

Class 2 Device Recall AFFIXUS Lag Screw Drill

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 Class 2 Recall
AFFIXUS Lag Screw Drill
see related information
Date Posted March 22, 2011
Recall Status1 Terminated on June 27, 2012
Recall Number Z-1643-2011
Recall Event ID 57916
Premarket Notification
510(K) Number
K100238 
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product AFFIXUS Lag Screw Drill, REF 2112-01-303, Non-Sterile, DePuy Orthopaedics, Inc., Warsaw, IN; DePuy International Leeds, England.
Code Information Lots: E2FGT4, E2FGS4, E28D64, E2FGR4, E2FGP4, and EL8EN4.
Recalling Firm/
Manufacturer
Depuy Orthopaedics, Inc.
700 Orthopaedic Dr
Warsaw, Indiana 46582-3994
Consumer Instructions Contact the recalling firm for information
Manufacturer Reason
for Recall
The firm recieved a complaint that the cannula for the drill is not the same size at both ends. The drill is grabbing the guidewire and advancing and not allowing to finish reaming, resulting in the possibility of the guide wire progressing through and penetrating the acetabulum.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action On 1/12/2011 DePuy contacted their distributors by telephone and directed the distributors to cancel all pending surgeries and discontinue use of the sets until the investigation is completed. On 1/14/2011 DePuy again contacted all distributors by telephone and directed all distributors to return the instruments to DePuy for inspection as part of the investigation.
Quantity in Commerce 296 units
Distribution Worldwide Distribution -- US, including the states of AR, AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NC, NV, NY, OH, PA, TN, TX, VA, WA, WI; and country of Switzerland.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = LXH and Original Applicant = DEPUY ORTHOPAEDICS, INC.
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