FDA Medical Device Recalls (openFDA)
Aesculap Implant Systems LLC: ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
- Recall number
- Z-1428-2022
- Recalling firm
- Aesculap Implant Systems LLC
- Product
- ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
- Status
- Terminated
- Initiated
- 2020-07-13
- Posted
- not on file
- Terminated
- 2024-04-26
- 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.
- 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