FDA-Device2026-10-22Class IIPACKAGING DEFECT
restor3d MTP Implant recalled for non-sterile units due to failed sterilization
What this means
Sixteen restor3d MTP foot implants were distributed without proper sterilization. The implants showed orange sterilization indicators, meaning they were never exposed to the sterilization process required to make them safe for surgery. These implants are used to treat arthritis and other conditions in the big toe joint.
- If you received this implant (Model 1103-161620, Lot A02979), contact your surgeon immediately.
- Do not use the implant if it has not yet been implanted.
- Surgeons should verify sterilization documentation before using any implants from this lot.
The agency's original wording
Hazard
Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.
Intended for
Adults
Illnesses reported
None reported
Sold states
U.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX.
Affected count
16
Manufactured in
4001 E Nc 54 Hwy, Suite 3160, Durham, North Carolina, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0264-2027More Restor3d recalls
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