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Terminated

Alteon Neck Preserving Stem, Standard Offset, Plasma Coated, Size 6

FDA Recall Z-1032-2017 · Posted None

Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeLZO
Date Initiated2016-11-07
Date Terminated2019-08-05
Product Quantity98

Reason for Recall

Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.

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 [email protected] or 1-800-392-2832.

Root Cause

Under Investigation by firm

Distribution Pattern

AZ, CA, CO, FL, IL, KS, MD, NJ, NY, OH, OK, TN, & VA; Germany, Italy, Japan, Spain, & Switzerland.

Official Source

View FDA Recall →

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

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