CLASS II Device recall · Reported 30 Dec 2020 · FDA Enforcement Report

Spinal Rod Cutter recalled by Zimmer Biomet

Zimmer Biomet is recalling Spinal Rod Cutter, distributed nationwide in the US. The recall was initiated on 20 Nov 2020 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll lots

Quantity recalled4713

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0696-2021
FDA event ID: 86869
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 20 Nov 2020
FDA classified: 22 Dec 2020
Reported: 30 Dec 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Hip & Knee Implants

Timeline

20 Nov 2020	Recall initiated by company
22 Dec 2020	Classified by FDA	+32 days
30 Dec 2020	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Device has the potential for fracture during use.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide

Questions about this recall

Why was it recalled?

Device has the potential for fracture during use.

Which lots are affected?

All lots

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Zimmer Biomet

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Reported	Class	Recall	Company	Reason	Where
23 Dec 2020Device	CLASS II	Polaris 5.5 Spinal System and Polaris 5.5/Cypher Spinal recalled	Zimmer Biomet	Device Malfunction	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D. recalled	Zimmer Biomet	Other	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Other	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Other	Nationwide
11 Nov 2020Device	CLASS II	ZCA All Longevity Crosslinked Polyethylene, I.D., Neutral, O.D recalled	Zimmer Biomet	Other	Nationwide

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