Recall Z-1638-2022— Aesculap Implant Systems LLC
Class II · Ongoing
Class II FDA medical device recall by Aesculap Implant Systems LLC, initiated 2022-07-15. It names one FDA 510(k) clearance: K180433. Product: Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014. Reason: Potential for the incorrect screw to be included in the package..
- Recalling firm
- Aesculap Implant Systems LLC
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2022-07-15
- Firm location
- Center Valley, PA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar, thoracic and sacral spine. Article Number: 52758014
Reason for recall
Potential for the incorrect screw to be included in the package.
Data sourced from openFDA. This site is unofficial and independent of the FDA.