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U.S. Department of Health and Human Services

Class 2 Device Recall 6.5mm Cancellous Bone Screw

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 Class 2 Recall
6.5mm Cancellous Bone Screw
see related information
Date Posted October 25, 2012
Recall Status1 Terminated on January 25, 2013
Recall Number Z-0139-2013
Recall Event ID 63321
Premarket Notification
510(K) Number
K931665 
Product Classification Screw, Fixation, Bone - Product Code HWC
Product 6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
Code Information Model Number 10-55-025, Lot Number 006A1057.
Recalling Firm/
Manufacturer
Encore Medical, Lp
9800 Metric Blvd
Austin, Texas 78758
Consumer Instructions No consumer action necessary
For Additional Information Contact Teffany Hutto
512-834-6255
Manufacturer Reason
for Recall
A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the package. It was thought that all of these screws were found in-house and were contained, but it was determined later that on
FDA Determined
Cause 2
PRODUCTION CONTROLS: Labeling Mix-Ups
Action Encore Medical sent a Urgent Field Safety Notice dated September 28, 2012, to all affected customers. This notice needs to be passed on all those who need to be aware within your organization or to any organization where the potentially affected devices have been transferred. Please contact Customer Service to place a replacement order and receive an RMA number. Return all affected devices using the RMA number. For further questions please call (512) 834-6255.
Quantity in Commerce 1 unit
Distribution Nationwide Distribution only to CA.
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 = HWC and Original Applicant = ENCORE ORTHOPEDICS, INC.
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