Reported Oct 28, 2026 · Ongoing · Updated Nov 2, 2026
Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Version: None…
restor3d Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: restor3d Inc. · 4001 E Nc 54 Hwy · Durham, NC · 27709
Is this the product you have?
- Generic Namerestor3d
- MTP Implant Generic NameMTP
- Implant Model/Catalog Number1103-161620
- Software VersionNone
- Product DescriptionThe 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 conditionshallux 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
- ComponentNot a component
- Lot codes and dates
- Lot CodeModel: 1103-161620
- UDI00840097505244
- LotA02979
- Amount recalled
- 16
Where it was sold
Why it was recalled
Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.
This product could cause temporary or reversible health problems — stop using it.
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