Humeral Stem 83mm(Size 17) Product Usage: Intended for recall
Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
Why was Humeral Stem 83mm(Size 17) Product Usage: Intended for 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
PN: 113633, LN: 421700, UDI# - (01) 00880304462632 (17) 271014 (10) 421700
- Product
- Humeral Stem 83mm(Size 17) Product Usage: Intended for primary and revision total shoulder arthroplasty as well as hemi-arthroplasty
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 12
- Distribution
- US Nationwide in the states of MN, NJ, CA, TX, ND
- Recall date
- March 21, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)