Ergo 3.2mm K-wire - Product Usage: The devices is used recall
Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a…
Why was Ergo 3.2mm K-wire - Product Usage: The devices is used recalled?
Potential for the wire to fracture at the threads and remain in the glenoid.
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?
Catalog Number: 321-52-06, All Serial Numbers
- Product
- Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a…
- Recalling firm
- Exactech, Inc.
- Quantity
- 158 devices
- Distribution
- US Nationwide including the states of AR, AZ, CA, CO, FL, IL, IN, KS, LA, MN, NY, NY, OH, SC, TN, TX, VA, WA.
- Recall date
- October 30, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)