Restor3d Inc.: Prosthesis, Toe, Hemi-, Phalangeal
- Recalling firm
- restor3d Inc.
- Product
- 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...
- Reason
- Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.
- Classification
- Class II
- Category
- medical device recall
- Country
- United States
- Agency
- FDA-DEVICES
- Recall date
- 2026-09-04
- Status
- Open, Classified
- Areas affected
- AL, AK, AZ, AR, CA, CO, CT, DE, FL, GA, HI, ID, ...
- Distribution
- U.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX.
Official recall notice from FDA-DEVICES
Recall details on Nibble Recalls: https://trynibble.app/recalls/fef745e8-a1b6-40db-afdd-49e2f6e9221a