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Terminated

Exactech Optetrak Logic CC 15mm Tibial Augment Screws

FDA Recall Z-2704-2017 · Posted 2017-06-19

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2017-04-07
Date Terminated2020-08-04
Product Quantity9 devices

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.

Firm Action

Consignees 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 [email protected] or 800-392-2832.

Root Cause

Process control

Distribution Pattern

CA and NY.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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