Aesculap Implant Systems LLC ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Brand
Aesculap Implant Systems LLC
Lot Codes / Batch Numbers
UDI-DI: 04046964719622
Products Sold
UDI-DI: 04046964719622
Aesculap Implant Systems LLC is recalling ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R due to 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 spina. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
An Urgent Field Safety Notification was issued July 13, 2020 sent USPS certified mail to distributors. The notification identified the product as Ennovate Removal Key (SZ380R) and addressed correct usage of said device, referencing section K of the Surgical Technique. Distributors are to identify and notify customers if further distributed. Distributors and customers are to review the notice, notify end users, and return the "Medical Device Field Safety Notification Form" to Aesculap via email at qa-recalls@aesculapusa.com.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026