Reported Apr 4, 2018 · Terminated

Persona Partial Knee spacer block instruments; (1) 8mm block, Model Number: 42-5399-035-08; (2) 9mm block, Model…

Zimmer Biomet, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Zimmer Biomet, Inc. · 56 E Bell Dr · Warsaw, IN · 46582-6989

Is this the product you have?

6 of 6 products

Products covered by this recall
Model / numberProduct as published
Persona Partial Knee spacer block instruments
42-5399-035-08(1) 8mm block
42-5399-035-09(2) 9mm block
42-5399-035-10(3) 10mm block
42-5399-035-12(4) 12mm block
42-5399-035-14(5) 14mm block, A spacer block is used to ensure the tibial resection Is sufficient and to verify limb alignment. After verification the distal femoral resecUon Is complete using the distal femoral cut slot in the spacer block. The spacer block determines how much distal femoral bone is resected.
Amount recalled
1023

This recall covers 20 products

The agency filed one notice per product. You are reading one of them; the other 19 are below.

7 more are in the archive.

Where it was sold

Why it was recalled

Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.

This product could cause temporary or reversible health problems — stop using it.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new Zimmer Biomet, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Apr 5, 2019 · Data as of Sep 19, 4:50 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.