restor3d Inc. recalls Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Version: None Product Description:…
Implants were found in the field with orange sterilzation indicators which means implants were not exposed to sterilization.
Read the official notice →- Date
- 2026-10-28
- Country
- United States
- Brand
- restor3d
- Product
- Generic Name: restor3d MTP Implant Generic Name: MTP Implant Model/Catalog Number: 1103-161620 Software Version: None Product Description:…
- Classification
- Class II
- Units
- U.S. Nationwide distribution in the states of FL, IL, NC, PA, SC, and TX.
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More restor3d recalls
- 2026-09-23
restor3d Inc. recalls Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants,…
- 2026-08-26
restor3d Inc. recalls Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030;…
Due to incorrect machining of peripheral screw hole resulting in potential for improper engagement of the peripheral screws.
- 2022-05-11
restor3d Inc. recalls Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018). Orthopedic manual surgical instrument
During re-work of disposable instruments to relabel for 4-year shelf-life of disposable instruments, parts got mixed into other lots.
FDA · Devicerestor3d Inc.US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.Official notice →restor3d Inc. recalls Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage. The kit includes 3 trials. Orthopedic manual…
Product labeled incorrectly. The lot was labeled with Small footprint when the product was Medium.
FDA · Devicerestor3d Inc.US Nationwide distribution in the states of KY, NC, NJ, TX, IN, VA and AL.Official notice →
USOther drugs & medical recalls in the United States
- 2026-10-28
Solstice Corporation recalls Xact mole marker for mammography Model/Catalog Number: M15RM
The radiopaque material may detach from the marker. In some cases, artifact was noted and attributed to the detached material.
FDA · DeviceSolstice CorporationWorldwide - US Nationwide distribution in the states and territory of CA, FL,…Official notice →Medtronic Neuromodulation recalls InterStim Percutaneous Extensions EXT 3560022 ISTM II PERC 3560022 EXT 3560030 ISTM MICRO PERC 3560030
Wrong lead or percutaneous extension selected. Use of an incompatible lead or percutaneous extension will prevent the system from working as intended and may result in delay of surgery or need for surgical replacement…
FDA · DeviceMedtronic NeuromodulationWorldwide distribution - US Nationwide and territory of Puerto Rico. The…Official notice →Medtronic MiniMed, Inc. recalls Generic Name: MiniMed Go App Generic Name: MiniMed Go App Model/Catalog Number: MMT-8600 (iOS), MMT-8601 (Android) Software Version:…
A software defect in which existing users who had previously configured and enabled the long-acting dose reminder feature in version 1.2.0 or earlier experienced failure of the long-acting dose reminder after updating…
FDA · DeviceMedtronic MiniMed, Inc.Worldwide - U.S. Nationwide distribution in the states of AL, CA, CT, FL, LA,…Official notice →Boston Scientific Cork, Ltd. recalls Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290
The product is defective due to insufficient UV curing of the hydrophilic coating which is present on the outer surface of the distal segment of the microcatheters and raised ridges on nitinol sleeves due to laser…
FDA · DeviceBoston Scientific Cork, Ltd.Worldwide distribution US Nationwide and territory of Puerto Rico. The…Official notice →Life Technologies Holdings Pte Ltd recalls Ion Torrent Genexus Dx with software, Catalog: A40003539, which supports the Ion Torrent Genexus Dx Integrated Sequencer
DNA or RNA sequencing system software has vulnerabilities.
FDA · DeviceLife Technologies Holdings Pte LtdUS Nationwide distribution in the states of PA, NC, CO, CA, LA, KY, NY, AZ,…Official notice →TECHNO-PATH MANUFACTURING LTD. recalls Techno-Path Multichem AE Unassayed Level 2 REF: AE622X
A routine stability studies have identified a stability drift affecting the Ammonia (NH4+) analyte in specific lots of Multichem AE quality control material. Additional testing confirmed that the labelled shelf-life…
FDA · DeviceTECHNO-PATH MANUFACTURING LTD.US Nationwide distribution in the state of Massachusetts.Official notice →