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Terminated

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.

FDA Recall Z-0696-2021 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHXZ
Date Initiated2020-11-20
Date Terminated2022-05-26
Product Quantity4713

Reason for Recall

Device has the potential for fracture during use.

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].

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Official Source

View FDA Recall →

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

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