Z-0696-2021Class II

Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter -

Name: Z-0696-2021 Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter -
Creator: Zimmer Biomet, Inc.
Published: 2020-11-20
License: https://open.fda.gov/license/

Zimmer GmbH / initiated 2020-11-20 / Terminated

FDA source

Zimmer Biomet, Inc. began a recall of Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for... on 2020-11-20. FDA classified it as Class II and gives the reason as "Device has the potential for fracture during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0696-2021
Classification: Class II
Status: Terminated
Initiated: 2020-11-20
Posted: 2020-12-22
Terminated: 2022-05-26
Recalling firm: Zimmer GmbH
Product: Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries.
Product code: HXZ Cutter, Wire
Reason for recall: Device has the potential for fracture during use.
FDA root cause: Under Investigation by firm
Action: The firm distributed Urgent Medical Device Recall and Notice of Discontinuation letters to affected customers on November 20, 2020. Customers were informed of the product's potential for fracture during use. Customers were asked to locate and quarantine affected product and to return all affected product to the firm. The firm is discontinuing this product; it will not longer be available. If you have questions regarding this recall, please contact the firm's customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].
Quantity in commerce: 4713
Distribution: Domestic distribution nationwide. Foreign distribution to Australia, China, Hong Kong, India, Japan, Korea, New Zealand, Taiwan, Singapore, Thailand, Canada, Netherlands, Argentina, Brazil, Mexico, Venezuela, Panama, and Chile.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0696-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0696-2021	Class II	Terminated	Voluntary: Firm initiated	2020-12-30	2020-12-22

Product code HXZ

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)