Class 2 Device Recall Femoral Stems

• Date Initiated by Firm: May 26, 2016
• Create Date: July 05, 2016
• Recall Status: Terminated on July 26, 2019
• Recall Number: Z-2127-2016
• Recall Event ID: 74317
• 510(K)Number: K063279
• Product Classification: Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
• Product: Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17.; Product Usage Femoral stems are indicated for use in skeletally mature individuals undergoing primary surgery for hip replacement due to osteoarthritis, rheumatoid arthritis, osteonecrosis, post-traumatic degenerative problems of the hip, and proximal femoral fractures. Also potentially indicated for ankylosing spondylitis, congenital hip dysplasia, revision of failed previous reconstructions where sufficient bone stock is present, and to restore mobility resulting from previous fusion. Intended for press-fit fixation.
• Code Information: Catalog #: 160-33-17; Serial#: 4192419, 4192420; Exp Date: 11/28/2020. Catalog #: 160-33-17; Serial#: 4223628, 4223629, 4223630, 4223631, 4223632, 4223633; Exp Date: 01/02/2021.
• Recalling Firm/ Manufacturer: Exactech, Inc.; 2320 NW 66th Ct; Gainesville FL 32653-1630
• For Additional Information Contact: Kaya Davis; 352-377-1140
• Manufacturer Reason for Recall: Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.
• FDA Determined Cause: Under Investigation by firm
• Action: Exatech sent an Important Notification letter dated May 16, 2016, to all affected customers. The letter notified customers of the product's incorrect Global Trade Item Number. Customers were instructed to cease distribution/use of the product, extend the information to accounts possessing the recalled product, identify and quarantine any devices in inventory, and to complete and return the Recall Inventory Response Form acknowledging that they received the recall notification. Customers were instructed to call 800-392-2832 with any questions. For questions regarding this recall call 352-377-1140.
• Quantity in Commerce: 8 units
• Distribution: Nationwide Distribuiton to OK, ME, NY, & Hawaii.
• 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 = LZO and Original Applicant = EXACTECH, INC.