Comprehensive Humeral Tray Taper Extraction Pliers recall: Sterility Concern
Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to…
Why was Comprehensive Humeral Tray Taper Extraction Pliers recalled?
There were unknown bioburden levels prior to sterilization, which may affect sterility of the product.
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?
Lot Numbers: 494350 494350R 233080 364910 489000 079630 516230 742760 362370 465800 197900 175110 175100
- Product
- Comprehensive Humeral Tray Taper Extraction Pliers - Replacement Tips, Model Number 110028522 - Product Usage: Intended to be used in surgery to…
- Recalling firm
- Biomet, Inc.
- Quantity
- 125
- Distribution
- Worldwide distribution - US Nationwide distribution including the states of AL, CO, KS, MA, MD, MI, MO, NH, NJ, and PA. The countries of Australia, Canada, India, and Netherlands.
- Recall date
- April 29, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)