Spinal fixation removal key fracture risk under misuse conditions
The ENNOVATE MIS removal key used in spinal fixation systems may fracture if the 90-degree angle is not maintained during use. A product redesign is underway.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for a spinal fixation surgical instrument with potential fracture or breakage under improper use; no illnesses or injuries have been reported, placing this in the 'risk-of-harm products where injury has not yet been reported' category.
Plain-English summary
The FDA has issued a Class II recall for the ENNOVATE MIS REMOVALKEY SHORT (product code SZ380R), a removal key used in spinal fixation surgical procedures. The device is manufactured by Aesculap Implant Systems LLC.
The recall addresses a fracture or breakage hazard: the spinal fixation arm at the downtube can fracture or break if the 90-degree angle is not maintained when using the removal key with the spinal fixation system.
The recall affects 17 units distributed nationwide in California, Colorado, Michigan, New Hampshire, Ohio, South Carolina, and Texas.
The manufacturer is redesigning the removal key to address this safety concern. Healthcare facilities should contact Aesculap Implant Systems LLC for guidance on the affected units.
The recalled product
- Product
- ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
- Manufacturer
- Aesculap Implant Systems LLC
- Hazard
- Affected units
- 17
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- UDI-DI: 04046964719622
Distribution
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