Equinoxe 44mm Short Humeral Head recall: Labeling Error
Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
Why was Equinoxe 44mm Short Humeral Head recalled?
Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.
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?
Serial Numbers 3597678 thru 3597713, 3609323 thru 3609358, 3616214 thru 3616249 and 3640539 thru 3640574.
- Product
- Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
- Recalling firm
- Exactech, Inc.
- Quantity
- 112 devices
- Distribution
- Worldwide Distribution - US Nationwide in the states of AK, AZ, CA, CO, FL, ID, ME, MN, NC, OH, OK, PA, RI, TN, VA and WA. and countries of Brazil and Canada.
- Recall date
- April 29, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)