Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
Reported: March 21, 2018 Initiated: December 8, 2017 #Z-0979-2018
Product Description
Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
Reason for Recall
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.
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 12
- Distribution
- US Nationwide in the states of MN, NJ, CA, TX, ND
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty. Recalled by Zimmer Biomet, Inc.. Units affected: 12.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 21, 2018. Severity: Moderate. Recall number: Z-0979-2018.
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