—#184727

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.

FDA product code: HXZ — Cutter, Wire
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: All lots

Why it was recalled

Device has the potential for fracture during use.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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 CorporateQuality.PostMarket@zimmerbiomet.com.

Recalling firm

Firm: Zimmer Biomet, Inc.
Address: 1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

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.

Timeline

Recall initiated: 2020-11-20
Terminated: 2022-05-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #184727. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.