Reported Feb 22, 2017 · Terminated
Vanguard Total Knee, PUNCH THRU TRL PLATES, 63 MM Item No: 32-487261, 67 MM Item No: 32-487262, 71 MM Item No:…
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?
- Vanguard Total Knee, PUNCH THRU TRL PLATES, 63
- MM Item No
32-48726167
- MM Item No
32-48726271
- MM Item No
32-48726375
- MM Item No32-487264
- and 79 MM Item No32-487265
- Lot codes and dates
- Vanguard Total Knee, PUNCH THRU TRL PLATES, 63
- MM Item No
32-48726167
- MM Item No
32-48726271
- MM Item No
32-48726375
- MM Item No32-487264
- and 79 MM Item No32-487265
- Lot No's
ZB160701ZB160702ZB160703ZB160701ZB160702ZB160701ZB160702ZB160703ZB160801ZB160802ZB160803ZB160801ZB160802
- Amount recalled
- 26
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Why it was recalled
Zimmer Biomet is conducting a medical device recall for ARCOS & TPRLC broaches and rasps due to potential alumina inclusions in the raw material batch used to produce the affected products. Inclusions contained within the finished product could lead to the cracking and separation of the instrument.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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