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.
FDA Recall Z-1225-2012 · Posted 2012-03-19
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Recalling FirmSmith & Nephew, Inc. Endoscopy Division
Recall StatusTerminated
Product CodeHWC
Date Initiated2012-02-06
Date Terminated2016-02-29
Product Quantity194 units
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).
Firm 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 [email protected]. 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.
Root Cause
Packaging process control
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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