Recall Z-1428-2022 ยท LXH Orthopedic Manual Surgical Instrument
Aesculap Implant Systems LLC
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
| Date | Jul 13, 2020 |
| Status | Terminated |
| Reason | 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. |
| Root cause | Component design/selection |
| Action | 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. |
| Quantity | 16 |
| Distribution | United States Nationwide distribution in the states of CA, CO, IL, MI, OH & TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.