Class II U.S. Food and Drug Administration

restor3d Inc recall: Implants were found in the field with orange sterilzation indicators

Recall published 5 days ago

Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.

The hazard: Lead or heavy metal content

Lead is the reason for this notice. The important thing is removing the source and asking about a blood test, in that order.

What the notice says: Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.

Why it matters: The product exceeds the federal limit on lead or another heavy metal. Lead harms the developing brain, and the damage builds quietly from small repeated exposures rather than arriving as a single dramatic poisoning.

Symptoms and when to call a doctor

The CDC states there is no known safe level of lead in a child’s blood, and that most children with elevated levels show no symptoms at all. That is why a blood lead test, not a symptom check, is the way to find out. Ask your paediatrician about testing if a child has handled, mouthed or worn the product regularly. Where symptoms do appear they are non-specific — irritability, poor appetite, stomach pain, tiredness, constipation or a drop in attention and learning.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
Z-0264-2027
Published
October 28, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
restor3d Inc.
Product type
Medical devices
Units affected
16
Distribution
Nationwide
Made in
United States
Lot / code info
Lot Code: Model: 1103-161620 UDI: 00840097505244 Lot: A02979
UPC codes
00840097505244

Products covered by this recall

Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Version: None Product Description: The restor3d Metatarsophalangeal (MTP) Implant is a sterile, single-use implant grade metal device, available in varied articulating surface coverages. The restor3d MTP implant is designed to replace the damaged articulating surface of the first metatarsal distal head. The device is intended for the treatment of patients with degenerative and post-traumatic arthritis in the first metatarsal joint in the presence of good bone stock and integrity of the first metatarsal head. This implant can also be used in the following clinical conditions: hallux valgus or hallux limitus, hallux rigidus, and an unstable or painful metatarsal/phalangeal (MTP) joint. The implant is a single use product intended to be press fit, with optional use of bone cement. The restor3d MTP Implant is comprised of a single laser powder bed fusion (LPBF) printed cobalt-chromium alloy (Co28Cr6Mo) part. The external surface of the implant that is intended to be in contact with the phalanx is mirror polished. Component: Not a component

Check your product

The notice names 4 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

UPC / barcode

Read the twelve digits under the barcode on the package.

  • 00840097505244

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • A02979

Model or item number

On the rating label, the box or the instruction sheet.

  • 1103-161620
  • 1103-161620 UDI

Codes are lifted verbatim from the FDA — Device enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Lead

restor3d Inc. — Lead is the reason for this notice. The important thing is removing the source and asking about a blood test, in that order.

  1. Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.
  2. Follow the remedy on this page — lead recalls almost always carry a full refund.
  3. Wash the hands of anyone who has been handling it, and wipe down the surfaces it has been sitting on.
  4. Ask your paediatrician whether a blood lead test is warranted, especially for a child under six or anyone pregnant.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • Several recalls now ask you to destroy the item and send a photo as proof. Register the claim before you do that, never after.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.
  • A repair kit is shipped free and is designed to be fitted at home; if you cannot fit it, ask whether they will arrange installation.

Company contact: restor3d Inc. — 4001 E Nc 54 Hwy, Durham, NC, 27709

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Device enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was restor3d Inc. medical devices recalled?

Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization. Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: UPC 00840097505244; lot code A02979; model number 1103-161620, 1103-161620 UDI. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Take the product away from children and stop using it — do not keep it for decoration where a child can reach it.

Can I get my money back?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

Where was the recalled product sold?

It was distributed nationwide.

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