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Terminated

ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

FDA Recall Z-1428-2022 · Posted None

Recalling FirmAesculap Implant Systems LLC
Recall StatusTerminated
Product CodeLXH
Date Initiated2020-07-13
Date Terminated2024-04-26
Product Quantity16

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.

Firm 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 [email protected].

Root Cause

Component design/selection

Distribution Pattern

United States Nationwide distribution in the states of CA, CO, IL, MI, OH & TX.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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