Z-2073-2017Class II

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

Name: Z-2073-2017 Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600
Creator: Biomet Microfixation, LLC
Published: 2017-04-11
License: https://open.fda.gov/license/

Biomet Microfixation / initiated 2017-04-11 / Terminated / root cause: packaging

FDA source

Biomet Microfixation, LLC began a recall of Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600 on 2017-04-11. FDA classified it as Class II and gives the reason as "Part of the number on the tray lid differ from the part number on the base". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2073-2017
Classification: Class II
Status: Terminated
Initiated: 2017-04-11
Posted: 2017-05-12
Terminated: 2019-08-06
Recalling firm: Biomet Microfixation
Product: Biomet Microfixation TraumaOne System Surgical Tray - Model # 46-1600
Product code: HWT Template
Reason for recall: Part of the number on the tray lid differ from the part number on the base.
Root cause tag: packaging
FDA root cause: Under Investigation by 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)
Quantity in commerce: 33 units
Distribution: AL, MO and UT Canada, Australia, Netherlands, and Egypt
Product codes and lots: Part Number 46-1610 // Lot Number 709730 Part Number 46-1610 // Lot Number 709740 Part Number 46-1620 // Lot Number 709710 Part Number 46-1620 // Lot Number 709720

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2073-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2073-2017	Class II	Terminated	Voluntary: Firm initiated	2017-05-24	2017-05-12

Product code HWT

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)