CLASS II Device recall · Reported 4 Dec 2019 · FDA Enforcement Report

ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp recalled

Zimmer Biomet is recalling ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp, distributed in 11 states. The recall was initiated on 6 Aug 2019 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel Number: 11032331 Lots: 784060, 662870

Quantity recalled73

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-0517-2020
FDA event ID: 84124
Recalling firm: Zimmer Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 6 Aug 2019
FDA classified: 22 Nov 2019
Reported: 4 Dec 2019
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Other Medical Devices

Timeline

6 Aug 2019	Recall initiated by company
22 Nov 2019	Classified by FDA	+108 days
4 Dec 2019	Published in enforcement report	+12 days

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

Reason for recall

The potential that the end of the shaft could fail to effectively mate with the broach with the Calcar Planar Shaft instrument, part number 110032331.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

ASI 2.0 Calcar Trimmer Shaft for Use with Biomet¿ Rasp, Model Number 110032331

Where it was distributed

CA, IN, MN, NJ, NY, AR, LA, OH, KY, TX, CO (US) CA, CN, NL (International)

Arkansas California Colorado Indiana Kentucky Louisiana Minnesota New Jersey New York Ohio Texas

Questions about this recall

Why was it recalled?

The potential that the end of the shaft could fail to effectively mate with the broach with the Calcar Planar Shaft instrument, part number 110032331.

Which lots are affected?

Model Number: 11032331 Lots: 784060, 662870

Where was it sold?

CA, IN, MN, NJ, NY, AR, LA, OH, KY, TX, CO (US) CA, CN, NL (International)

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.

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