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U.S. Department of Health and Human Services

Class 2 Device Recall Tibial Augment Screw

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 Class 2 Device Recall Tibial Augment Screwsee related information
Date Initiated by FirmApril 07, 2017
Date PostedJune 19, 2017
Recall Status1 Terminated 3 on August 04, 2020
Recall NumberZ-2704-2017
Recall Event ID 77514
510(K)NumberK150890 
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
ProductExactech Optetrak Logic CC 15mm Tibial Augment Screws
Code Information Catalog No. 02-012-50-9015; Serial #'s 4739530, 4739531, 4739532, 4739533, 4739534, 4739535, 4739536, 4739537, and 4739538.
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information ContactKaya Davis
800-392-2832
Manufacturer Reason
for Recall		Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.
FDA Determined
Cause 2		Process control
ActionConsignees were initially contacted by phone on 04/07/2017. Consignees were sent a recall notice by mail, dated 04/13/2017. The notice requested that consignees immediately cease distribution/use of product, that the recall Extend the information to accounts in possession of the product Identify/quarantine any subject devices in your inventory Complete & return the attached Recall Inventory Response Form to Exactech within 5 business days at 2411 NW 66th Ct, Gainesville, FL 32653 or faxed to 352-337-3915. Questions from customers are to be directed to Kaya Davis at kaya@exac.com or 800-392-2832.
Quantity in Commerce9 devices
DistributionCA and NY.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = JWH
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