ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
- Company
- Aesculap Implant Systems Llc
- Recall Initiated
- July 13, 2020
- Terminated
- April 26, 2024
- Recall Number
- Z-1428-2022
- Quantity
- 16
- Firm Location
- Center Valley, PA
Reason for Recall
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.
Distribution
United States Nationwide distribution in the states of CA, CO, IL, MI, OH & TX.
Lot / Code Info
UDI-DI: 04046964719622
Root Cause
Component design/selection
Action Taken
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.