Recall Z-1428-2022— Aesculap Implant Systems LLC
Class II · Terminated
Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2020-07-13, terminated 2024-04-26. FDA's recall record names no specific 510(k) clearance for this event. Product: ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R. 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..
- Recalling firm
- Aesculap Implant Systems LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-07-13
- Terminated
- 2024-04-26
- Firm location
- Center Valley, PA, United States
Product description
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.