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. Redesign of removal key.
Recommended Action
Per FDA guidance
An Urgent Field Safety Notification was issued November 18, 2020 sent USPS certified mail to distributors regarding removal of Ennovate Removal Key Short (SZ380) from the field. The affected Ennovate MIS Removal Key Short (SZ380R) in the field is to be exchanged with an improved design version under the same article number manufactured after June 01, 2020. Distributors are to identify and notify customers of this action. Distributors and customers are to identify the affected version in inventory and return it to Aesculap and submit the Acknowledgment Form 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