EXACTECH Equinoxe Reverse Starter Reamer recall
EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01
Why was EXACTECH Equinoxe Reverse Starter Reamer recalled?
Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
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?
All Lots
- Product
- EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01
- Recalling firm
- Exactech, Inc.
- Quantity
- 382
- Distribution
- AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, Hawaii and Puerto Rico Australia, Austria, Brazil, Canada, China, France, Germany, Greece, India, Italy, Korea, Luxembourg, Singapore, South Africa, Spain, Sweden, Switzerland, The Netherlands and United Kingdom
- Recall date
- July 12, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)