Threaded Offset Cup Impactor - Product Usage: To assist recall
Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional…
Why was Threaded Offset Cup Impactor - Product Usage: To assist recalled?
The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
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 181-02-01, Lot Numbers 103071001, UDI Number 10885862520623. Expansion on 09/09/2019 to include Lot Number 8182001
- Product
- Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional…
- Recalling firm
- Exactech, Inc.
- Quantity
- 22 devices
- Distribution
- US distribution to AR, CA, FL, IL, IN, NY, SC, TX.
- Recall date
- September 18, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)