Reported Mar 21, 2018 · Terminated
Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as…
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?
- Humeral
- Stem 83mm(Size 17) Product UsageIntended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
- Lot codes and dates
- PN113633
- LN421700, UDI# - (01) 00880304462632 (17) 271014 (10) 421700
- Amount recalled
- 12
This recall covers 59 products
The agency filed one notice per product. You are reading one of them; the other 58 are below.
46 more are in the archive.
Where it was sold
Why it was recalled
Zimmer Biomet is conducting a medical device recall for two lots of Comprehensive Humeral stems. The lots were commingled during the manufacturing process and were etched with incorrect lot numbers. The size difference between the two stem sizes is 1.1 inches. It is visually recognizable by the user that the box label does not match the contents of the box.
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.
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