restor3d MTP Implant Recall Due to Sterilization Indicator Failure
restor3d Inc. is recalling 16 restor3d MTP Implants because field findings showed orange sterilization indicators, meaning the devices were not exposed to sterilization.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is an FDA Class II for MTP implants found with orange sterilization indicators, indicating they were not exposed to sterilization. The source does not report any illnesses, injuries, or deaths.
Plain-English summary
restor3d Inc. is recalling 16 units of the restor3d Metatarsophalangeal (MTP) Implant, model 1103-161620, lot A02979. The recall was initiated because implants were found in the field with orange sterilization indicators, which indicates that the devices were not exposed to sterilization.
The affected devices are sterile, single-use, implant-grade metal devices designed to replace the damaged articulating surface of the first metatarsal distal head. The implants are distributed nationwide in Florida, Illinois, North Carolina, Pennsylvania, South Carolina, and Texas.
The source text does not report any illnesses, injuries, or deaths associated with this recall. Patients who have received these implants should contact their healthcare provider for guidance.
The recalled product
- 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…
- Manufacturer
- restor3d Inc.
- Hazard
- Affected units
- 16
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Code: Model: 1103-161620 UDI: 00840097505244 Lot: A02979
Distribution
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