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Terminated

Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600

FDA Recall Z-2073-2017 · Posted None

Recall StatusTerminated
Product CodeHWT
Date Initiated2017-04-11
Date Terminated2019-08-06
Product Quantity33 units

Reason for Recall

Part of the number on the tray lid differ from the part number on the base.

Firm Action

On April 11, 2017 the firm sent notifications to all affected US and International distributors, which will include instructions for returning affected products. All distributors will be notified via electronic mail, and US distributors with product, will be notified via courier. o Distributors will be sent a letter identifying the issue and their responsibilities. These responsibilities include locating and removing the product in their territory, as well as identifying hospitals which currently have the product. o Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the additional accounts form provided in the letter. o Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: - Assisting the Zimmer Biomet sales representative with the quarantine of the product and completion and return of the Attachment 1 form. - Complete and return Attachment 1 (Acknowledgement of Responsibility) to the fax number or email address provided. For more information contact [email protected] or 904-367-7133 (8:am - 5pm EST)

Root Cause

Under Investigation by firm

Distribution Pattern

AL, MO and UT Canada, Australia, Netherlands, and Egypt

Official Source

View FDA Recall →

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

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