Recall Z-1429-2022 ยท LXH Orthopedic Manual Surgical Instrument
Aesculap Implant Systems LLC
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
| Date | Nov 18, 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. Redesign of removal key. |
| Root cause | Component design/selection |
| Action | 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.c |
| Quantity | 17 |
| Distribution | United States Nationwide distribution in the states of CA, CO, MI, NH, OH, SC & TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.