| Class 2 Device Recall Alteon Neck Preserving Stem | |
Date Initiated by Firm | November 07, 2016 |
Create Date | January 17, 2017 |
Recall Status1 |
Terminated 3 on August 05, 2019 |
Recall Number | Z-1032-2017 |
Recall Event ID |
75989 |
510(K)Number | K141821 |
Product Classification |
Prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented - Product Code LZO
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Product | Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6 |
Code Information |
Serial No. 3787445-3787447, 3868023-3868072, 4209114-4209135, 4318092-4318102, 4350860-4350869, 4386939, 4420620-4420644, 4558261-4458262; Catalog No. 162-00-06; UDI: 10885862262776 |
Recalling Firm/ Manufacturer |
Exactech, Inc. 2320 NW 66th Ct Gainesville FL 32653-1630
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For Additional Information Contact | Kaya Davis 352-377-1140 |
Manufacturer Reason for Recall | Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another. |
FDA Determined Cause 2 | Under Investigation by firm |
Action | In the recall notice sent to agents, dated 11/01/2016, recipients are instructed to cease product distribution, extend knowledge of the recall to their accounts, identify and quarantine any product in inventory, and complete and return the Recall Inventory Response Form. Consignees are instructed to contact their Exactech Representative within 5 days of receipt of the notice to confirm product quantities at each location. Consignees with any questions are instructed to contact Kaya Davis at kaya@exac.com or 1-800-392-2832. |
Quantity in Commerce | 98 |
Distribution | AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = LZO
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