Aesculap ENNOVATE Set Screws Recall: Incorrect Screw Risk

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Recalling firmAesculap Implant Systems LLC3773 Corporate Pkwy · Center Valley, PA 18034-8217

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✎ GovInfoNow plain-language explainer

What happened, in plain English

Aesculap is recalling sterile set screws used for spinal stabilization because the package might contain the wrong screw. This could lead to improper spinal fixation if the incorrect screw is used during surgery.

Why it’s dangerous

The package may contain the wrong screw type, which could lead to improper spinal fixation if used during surgery. This might cause instability or complications during spinal stabilization procedures.

Who’s affected

Surgical teams and patients who received the recalled set screws for spinal stabilization procedures. The risk is low as the hazard involves potential incorrect screw inclusion rather than immediate harm.

How to tell if you have this one

Check for the article number 52758014 or lot number 52758014 on the packaging. The product is used for spinal stabilization in the lumbar, thoracic, and sacral regions.

Brand
Aesculap
Category
Medical device

Based on the official FDA remedy

What to do — step by step

Check Package Contents
Verify that the package contains the correct screw type by checking the article number or lot number on the packaging.

✎ GovInfoNow

Questions people ask

What is the specific product being recalled?

Aesculap ENNOVATE sterile set screws used for spinal stabilization, with article number 52758014 and lot number 52758014.

How can I tell if I have the recalled product?

Look for the article number 52758014 or lot number 52758014 on the packaging.

What should I do if I have the recalled product?

Check the package contents to ensure the correct screw type is included; no immediate action is required beyond verification.

Take action

Contact Aesculap

We’ve drafted a message you can send Aesculap to request your refund or repair — edit it as you like.

✉️ Open in email

Subject: Recall Z-1638-2022 — Aesculap Aesculap

Hello,

I own a Aesculap that is covered by recall Z-1638-2022 from Aesculap.

I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this?

Thank you.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #Z-1638-2022 (July 15, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-1638-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.

Aesculap Implant Systems LLC recalls Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the

Lower-risk recall