Spinal Fixation Device Removal Key Recalled Due to Potential Fracture Risk
Aesculap Implant Systems recalls ENNOVATE MIS REMOVALKEY SHORT due to fracture risk if removal key is not used at 90-degree angle. Affected units distributed in CA, CO, IL, MI, OH, and TX.
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: Class II FDA recall of a spinal fixation device component with structural failure risk (fracture or breakage). Qualifies as a risk-of-harm product per the severity rubric; no injuries reported in the source text.
Plain-English summary
Aesculap Implant Systems LLC is recalling the ENNOVATE MIS REMOVALKEY SHORT (product code SZ380R), a removal key component used with spinal fixation systems. The recall addresses a structural defect: the spinal fixation arm may fracture or break at the downtube instrument if the removal key is not positioned at a 90-degree angle during use.
Sixteen units of the recalled device have been distributed across the United States in California, Colorado, Illinois, Michigan, Ohio, and Texas. This structural defect could prevent the device from functioning as intended during clinical use.
Healthcare providers and patients who have this product should ensure the removal key is used at the correct 90-degree angle to prevent device failure. Contact Aesculap Implant Systems LLC for information about product disposition, replacement, or instructions for safe continued use.
The recalled product
- Product
- ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
- Manufacturer
- Aesculap Implant Systems LLC
- Category
- Medical Device — Spinal Fixation
- Affected units
- 16
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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