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U.S. Department of Health and Human Services

Medical & Radiation Emitting Device Recalls
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 Class 2 Recall
6.5mm Cancellous Bone Screw		see related information
Date Posted October 25, 2012
Recall Number Z-0139-2013
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
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
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.
 
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