Optimus Fixed Awl recall
Optimus Fixed Awl
Why was Optimus Fixed Awl recalled?
Complaints that the tip of the awl broke after impaction during surgery.
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?
Part Number 139005 - Lot Number 182-16146
- Product
- Optimus Fixed Awl
- Recalling firm
- Amendia, Inc
- Quantity
- 9 devices
- Distribution
- US Distribution to the states of : FL, GA. IL, MO, TX
- Recall date
- December 28, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)