Class 2 Device Recall AcuMatch MSeries Straight and Curved Fluted Stem Segments.

• Date Initiated by Firm: July 21, 2006
• Date Posted: June 09, 2007
• Recall Status: Terminated on May 06, 2012
• Recall Number: Z-0916-2007
• Recall Event ID: 37788
• 510(K)Number: K993736
• Product Classification: Stem Segments - Product Code LPH
• Product: AcuMatch M-Series Straight Fluted Stem Segment and AcuMatch M-Series Curved Fluted Stem Segment. Catalog numbers 150-07-19 and 150-07-44.
• Code Information: 0797860, 0797861, 0797862, 0797857, 0797858, 0797859
• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 NW 66th Ct; Gainesville FL 32653-1630
• Manufacturer Reason for Recall: The packaging was mislabeled: Exterior and interior packaging on the device was labeled with catalog number 150-07-19 15mm x 200mm, however, the actual part inside the packaging was a 21mm x 200mm (catalog number 150-07-44) device.
• FDA Determined Cause: Other
• Action: The consignees were contacted by fax and email (dated July 21, 2006) to inform them of the recall requesting return of product
• Quantity in Commerce: 6
• Distribution: World wide-Domestically distributed to one account in Alabama and internationally to Columbia and Australia.
• 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 = LPH