Ennovate MIS Removalkey Short recall
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Why was Ennovate MIS Removalkey Short recalled?
Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system.
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?
UDI-DI: 04046964719622
- Product
- ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
- Recalling firm
- Aesculap Implant Systems LLC
- Quantity
- 16
- Distribution
- United States Nationwide distribution in the states of CA, CO, IL, MI, OH & TX.
- Recall date
- July 27, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)