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U.S. Department of Health and Human Services

Class 2 Device Recall BIOSURE HA Interference Screw

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 Class 2 Recall
BIOSURE HA Interference Screw
see related information
Date Posted March 19, 2012
Recall Status1 Open
Recall Number Z-1225-2012
Recall Event ID 61138
Premarket Notification
510(K) Number
K080358 
Product Classification Screw, Fixation, Bone - Product Code HWC
Product Smith & Nephew BIOSURE HA Interference Screw, 7 mm x 25 mm Catalog Number: 72201772. The BIOSURE HA Interference Screw is indicated for fixation of bone-tendon-bone or soft tissue grafts during anterior/posterior cruciate ligament (ACL/PCL) reconstruction procedures.
Code Information Lot Number: 50397157
Recalling Firm/
Manufacturer
Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover, Massachusetts 01810-1031
Consumer Instructions Contact the recalling firm for information
For Additional Information Contact Xianjun (Catherine) Chen
978-749-1073
Manufacturer Reason
for Recall
Mislabeled: The device was labeled as a standard thread screw (P/N 72201772) on pouch and box, however the device contained in the packaging is a reverse thread screw (P/N 72201773).
FDA Determined
Cause 2
PRODUCTION CONTROLS: Packaging Process Control
Action Smith & Nephew Endoscopy sent an "URGENT-PRODUCT RECALL 1st NOTIFICATION" dated February 2012 to all affected customers. The letter identifies the product, problem, and the actions to be taken by the customers. The letter instructs customers to inspect their inventory and quarantine any affected product. For instructions on returning product, contact the Smith & Nephew Endoscopy Division Returns Group at 800-343-5717 ( 0ption 3) or email to endo.andreturns@smith-nephew.com. Additionally, customers were asked to complete the bottom portion of the letter and to fax it to 1-508-261-3620. Contact the Smith & Nephew Endoscopy Division for questions regarding this notice at 1-508-261-3731.
Quantity in Commerce 194 units
Distribution Worldwide Distribution-USA (nationwide) and the states of AK, AZ, CA, CO, CT, IA , MD, MI, MN, MO, MS, NE, OH, OK, PA, SC, and VA and the countries of Australia, Canada, Germany, South Korea, Spain, Switzerland, Thailand, and United Kingdom.
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 = SMITH & NEPHEW INC., ENDOSCOPY DIV.
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