CLASS II ONGOING Device recall · Reported 28 Oct 2026 · FDA Enforcement Report
Metatarsophalangeal (MTP) Implant is a sterile recalled by restor3d
restor3d is recalling Metatarsophalangeal (MTP) Implant is a sterile, single-use implant grade metal device, distributed nationwide in the US. The recall was initiated on 4 Sep 2026 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0264-2027
- FDA event ID
- 99940
- Recalling firm
- restor3d, Durham, NC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 4 Sep 2026
- FDA classified
- 22 Oct 2026
- Reported
- 28 Oct 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Medical Software
Timeline
| 4 Sep 2026 | Recall initiated by company | |
| 22 Oct 2026 | Classified by FDA | +48 days |
| 28 Oct 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
U.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX.
Nationwide FloridaIllinoisNorth CarolinaPennsylvaniaSouth CarolinaTexas
Questions about this recall
Why was it recalled?
Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.
Which lots are affected?
Lot Code: Model: 1103-161620 UDI: 00840097505244 Lot: A02979
Where was it sold?
U.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 3 Nov 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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