FDA Medical Device Recalls (openFDA)
Aesculap Implant Systems LLC: ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
- Recall number
- Z-1429-2022
- Recalling firm
- Aesculap Implant Systems LLC
- Product
- ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
- Status
- Terminated
- Initiated
- 2020-11-18
- Posted
- not on file
- Terminated
- 2024-12-23
- 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.com.
- Quantity
- 17
- Distribution
- United States Nationwide distribution in the states of CA, CO, MI, NH, OH, SC & TX.
- Lot, serial or model codes
- UDI-DI: 04046964719622
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 2916714
- Firm city
- Center Valley
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28