Drugs & medicalClass II

Aesculap Implant Systems LLC recalls ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R

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.

Read the official notice →
Date
2022-07-27
Country
United States
Brand
Aesculap Implant Systems
Product
ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Classification
Class II
Units
United States Nationwide distribution in the states of CA, CO, IL, MI, OH & TX.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

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