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Terminated

ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

FDA Recall Z-1429-2022 · Posted None

Recalling FirmAesculap Implant Systems LLC
Recall StatusTerminated
Product CodeLXH
Date Initiated2020-11-18
Date Terminated2024-12-23
Product Quantity17

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. Redesign of removal key.

Firm 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 [email protected].

Root Cause

Component design/selection

Distribution Pattern

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

Official Source

View FDA Recall →

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

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