Kico Knee Innovation Company recalls Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version:…
Complaint identified issue with AI surgical planning software that may result in implant malalignment and/or decrease range of motion.
Read the official notice →- Date
- 2025-10-22
- Country
- United States
- Brand
- Kico Knee Innovation
- Product
- Brand Name: ARVIS Product Name: ARVIS" Shoulder Model/Catalog Number: IN-27300, Arvis Surgical Planning Software Software Version:…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of IN, MN, MO, OH, FL, IL, RI, KY,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Kico Knee Innovation recalls
- 2026-08-26
USKico Knee Innovation Company recalls Brand Name: Kico Knee Innovation Product Name: ARVIS SURGICAL NAVIGATION SYSTEM GEN 2 Model/Catalog Number: IN-29200 Software…
Due to an internal sensor issue, image displayed with eyepiece may appear tilted relative to the eyepiece housing
FDA · DeviceKico Knee Innovation CompanyConsignee Consignee Number Region Device Quantity RFK MEDICAL CE102 RICHMOND…Official notice →- 2026-06-10
- US
Kico Knee Innovation Company recalls Arvis Hip & Knee 2.0 Instrument Set, REF: IN-21200 containing one of the following components: IN-10500, Impactor V-Block Assembly;…
The Impactor V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.
FDA · DeviceKico Knee Innovation CompanyWorldwide - US Nationwide distribution in the states of MS, CA, IA, IN, MI,…Official notice → - US
Kico Knee Innovation Company recalls Arvis Hip & Knee 3.0 Instrument Set, REF: IN-28000 containing one of the following components: IN-10500, Impactor V-Block Assembly;…
The V-Block Assembly and Trackers A, B, C and E may exhibit signs of early wear and/or corrosion on the exposed magnet face.
FDA · DeviceKico Knee Innovation CompanyWorldwide - US Nationwide distribution in the states of MS, CA, IA, IN, MI,…Official notice →
Other drugs & medical recalls in the United States
- 2025-10-22
- US
BioPro, Inc. recalls BioPro Bipolar Head Product ID/Description 18130 BIPOLAR HEAD 38MM 18131 BIPOLAR HEAD 39MM 18132 BIPOLAR HEAD 40MM 18133 BIPOLAR HEAD 41MM…
Potential packaging issue that could compromise the sterile barrier. Defect may result in loss of sterility of the device, presenting potential risk of infection if device is implanted.
- US
Ethicon Endo-Surgery Inc recalls ECHELON LINEAR Cutters Reload 80 mm Blue, intended for transection, resection, and/or creation of anastomoses, Product Number GLC80
The devices were shipped unsterilized.
FDA · DeviceEthicon Endo-Surgery IncInternational distribution to the countries of United Arab Emirates.Official notice → - US
Lutronic Corporation recalls XERF EFFECTOR 60. Electrosurgical unit.
Manufacturing defects in devices manufactured from 4/1/25 to 8/20/25 can on rare occasions result in adverse events for patients.
FDA · DeviceLutronic CorporationWorldwide - US Nationwide distribution in the states of CA, IL, MA, NJ, NY,…Official notice → - US
Boston Scientific Corporation recalls TENACIO Pump without InhibiZone; UPN: 72404420;
The potential for devices to experience inflation and/or deflation performance issues or difficulties.
FDA · DeviceBoston Scientific CorporationWorldwide distribution - US Nationwide and the country of Canada.Official notice → - US
Medline Industries, LP recalls Medline Adult Anesthesia Set, REF DYNJ39985G
Specific items and lots of Medline Kits may contain Clearlink IV Sets which Baxter recalled due to customer reports of leaking.
- US
Iantrek Inc. recalls C-Rex UNO Microinterventional Goniotomy Instrument. Model Number: CRX-120. Product Description: The C-Rex UNO Microinterventional…
Potential for compromised integrity of the sterile packaging.
FDA · DeviceIantrek Inc.US Nationwide distribution in the states of AL, AZ, CA, CT, DE, FL, GA, ID,…Official notice →