Aesculap ENNOVATE Spine Implants Recalled for Incorrect Screw Inclusion
Aesculap Implant Systems LLC recalls ENNOVATE SET SCREW spine implants because packages may contain incorrect screws. Six units distributed in Georgia and Texas.
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: This is a risk-of-harm product (spine surgical implants) where incorrect components could compromise surgical safety. No injuries have been reported, but the potential for incorrect hardware in spinal stabilization procedures represents a significant patient safety concern.
Plain-English summary
Aesculap Implant Systems LLC is recalling ENNOVATE SET SCREW STERILE spine implants (Lot Number 52758014, Article Number 52758014). These implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic, and sacral spine.
The recall was initiated due to the potential for incorrect screws to be included in product packages. Six units from the affected lot were distributed in Georgia and Texas.
Healthcare facilities and surgeons who received this product should contact Aesculap Implant Systems LLC for further information and guidance on inventory verification and use.
The recalled product
- Product
- Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
- Manufacturer
- Aesculap Implant Systems LLC
- Affected units
- 6
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)
- GUIDID: 04046964989728 Lot Number: 52758014
Distribution
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