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Terminated

Catalog 314-13-33, Equinoxe Cage Glenoid, Posterior Augment, Right, Medium

FDA Recall Z-0460-2021 · Posted None

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeKWS
Date Initiated2020-10-06
Date Terminated2023-11-13
Product Quantity40 devices

Reason for Recall

The product may be mislabeled.

Firm Action

Exactech distributed the recall notice to consignees in possession of affected inventory worldwide on 10/06/2020. Consignees have been instructed to: -Immediately cease distribution or use of this product. -Extend the information to their accounts that may have this product in their possession. -Identify and quarantine any of the subject devices in their inventory. -Complete and return the attached Recall Inventory Response Form to Exactech.

Root Cause

Packaging process control

Distribution Pattern

US consignees - AZ, CA, CO, FL, IL, IN, KY, LA, OH, OK, MD, ME, MN, NV, NY, SC, TN, TX, VA, WA, WI International consignees - Australia, Japan, and United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113309EXACTECH EQUINOXE CAGE GLENOIDSExactech, Inc. · 2011-12-08

Official Source

View FDA Recall →

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

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