Class 2 Device Recall TruFit

• Date Initiated by Firm: September 29, 2006
• Date Posted: December 30, 2006
• Recall Status: Terminated on August 09, 2007
• Recall Number: Z-0440-2007
• Recall Event ID: 36521
• 510(K)Number: K040047
• Product Classification: Bone plug - Product Code MQV
• Product: TruFit CB Plug Size Code Red, 7mm; quantity 1; Part #605-001-03; product labeled as sterile; manufactured by OsteoBiologics, Inc., San Antonio, TX.
• Code Information: 051024-14 and 011-051024-14.
• Recalling Firm/ Manufacturer: Smith & Nephew, Inc. Endoscopy Division; 150 Minuteman Drive; Andover MA 01810-1031
• Manufacturer Reason for Recall: Mis-packaging-product in the package may be a different size than indicated on the labeling.
• FDA Determined Cause: Other
• Action: Firm notified customers of recall by letter sent via FedEx on 09/29/06.
• Quantity in Commerce: 32
• Distribution: Nationwide-Product distributed to distributors, sales reps and hospitals in AL, CA, FL, IL, NJ, NM, NY, PA, TX and UT.
• 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 = MQV and Original Applicant = OSTEOBIOLOGICS, INC.