M/L Taper Hip Prosthesis Extended Offset recall: Labeling Error
M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
Why was M/L Taper Hip Prosthesis Extended Offset recalled?
The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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?
Item Number: 00771100640, UDI-DI: 00889024131699, Lot Number: 65236202; Item Number: 00771100440, UDI-DI: 00889024131613, Lot Number: 65249215
- Product
- M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)
- Recalling firm
- Zimmer, Inc.
- Quantity
- 24 units
- Distribution
- Worldwide - US Nationwide distribution in the states of AL, CA, GA, MI, NJ, PA, TN, and WI. The countries of Brazil, Canada, Netherlands.
- Recall date
- September 13, 2023
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)