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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 Device Recall BIOSURE HA Interference Screw see related information
Date Initiated by Firm February 06, 2012
Date Posted March 19, 2012
Recall Status1 Terminated 3 on February 29, 2016
Recall Number Z-1225-2012
Recall Event ID 61138
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/
Smith & Nephew, Inc. Endoscopy Division
150 Minuteman Drive
Andover MA 01810-1031
For Additional Information Contact Xianjun (Catherine) Chen
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
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 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 = HWC and Original Applicant = SMITH & NEPHEW INC., ENDOSCOPY DIV.