Drugs & medicalClass II

Onkos Surgical, Inc. recalls Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M

Personalized pelvic implants inadvertently mixed up and distributed to incorrect customers.

Read the official notice →
Date
2026-10-14
Country
United States
Brand
Onkos Surgical
Product
Onkos Surgical Inc. My3D Personalized Pelvic Implant, Porous, Left REF PV-ACREC-04M
Classification
Class II
Units
US Nationwide distribution in the states of North Carolina, and California.
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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 Onkos Surgical recalls

  1. 2025-09-03
  2. US
    Drugs & medicalClass II

    Onkos Surgical, Inc. recalls ELEOS SEGMENTAL LIMB SALVAGE SYSTEM, ELEOS STEM EXTENSION, STRAIGHT, SPLINED, SLOTTED. Canal filling stem implants.

    Unidentified substance of unknown impact was identified on devices during a retrospective evaluation.

    FDA · DeviceOnkos Surgical, Inc.US Nationwide distribution in the states of AK, AZ, CA, FL, GA, IL, IN, KS,…Official notice →
  3. 2025-07-09
  4. US
    Drugs & medicalClass II

    Onkos Surgical, Inc. recalls My3D Personalized Solutions Humeral Cup, Model Number: C24-0223-0003. It is a component of a Custom Constrained Shoulder Arthroplasty Device

    Required inspections were not performed on finished product prior to release and distribution.

    FDA · DeviceOnkos Surgical, Inc.US Nationwide distribution in the state of Maryland.Official notice →
  5. 2025-06-04
  6. US
    Drugs & medicalClass II

    Onkos Surgical, Inc. recalls a. Segmental Stem, Cemented, Straight, 100MM, 1 EACH; Model Numbers: CS-09100-03M, CS-10100-03M. b. Segmental Stem, Cemented, Straight,…

    Potential for breach of Tyvek seals.

    FDA · DeviceOnkos Surgical, Inc.Product was shipped from Onkos' distribution in Olive Branch, MS to consignees…Official notice →
  7. US
    Drugs & medicalClass II

    Onkos Surgical, Inc. recalls ELEOS MALE-FEMALE MIDSECTION 40MM. Part Number: 25001040E. Component of ELEOS Limb Salvage System

    Potential challenge with intraoperative assembly of the external taper of a single midsection with the internal taper of a mating proximal femur.

    FDA · DeviceOnkos Surgical, Inc.US Nationwide distribution in the states of AZ, CA, FL, FL, MD, MO, NC, TN.Official notice →
  8. US
    Drugs & medicalClass II

    Onkos Surgical, Inc. recalls ELEOS COLLAR STEM, CEMENTED, FLUTED, 15MM X 120MM. Model Number: HC-15120-03M. Component of Limb Salvage System with BioGrip.

    Mislabeling of 13mm Modular Segmental Stem package (HC-13120-03M) which included an implant that was 15mm in diameter (HC-15120-03M) instead of being 13mm as stated on the package. The corresponding 15mm cemented stems…

    FDA · DeviceOnkos Surgical, Inc.US Nationwide distribution in the states of California, Kentucky, and Wisconsin.Official notice →
All 6 Onkos Surgical recalls →

Other drugs & medical recalls in the United States

  1. 2026-10-14
  2. US
    Drugs & medicalClass II

    Canon Medical System, USA, INC. recalls Alphenix INFX-8000C/B5

    Loosening of the bolts securing the longitudinal movement mechanism may cause the tabletop to shift, resulting in [positional/imaging/patient] misalignment and a longitudinal motion error

    FDA · DeviceCanon Medical System, USA, INC.US Nationwide distribution in the state of ID.Official notice →
  3. US
    Drugs & medicalClass II

    POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC recalls SEDIPLAST; Model/Catalog Numbers: S-100 and S-1000;

    During use of an affected tube, the operator may encounter increased resistance when inserting the pipette. The resulting pressure buildup may cause the tube cap to detach or be forcibly ejected, potentially resulting…

    FDA · DevicePOLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLCWorldwide - US Nationwide distribution in the states and territory of AK, AR,…Official notice →
  4. US
    Drugs & medicalClass II

    AVID Medical, Inc. recalls ROBOTIC PROSTATECTOMY PACK; Model/Item Number (Kit): NAMC423-11;

    Product may be potentially contaminated with a lubricant used during the manufacturing process.

    FDA · DeviceAVID Medical, Inc.US Nationwide distribution in the states of AZ, CA, FL, MD, NE, TX.Official notice →
  5. US
    Drugs & medicalClass II

    Nihon Kohden America LLC recalls Product Name: Nihon Kohden CNS-6200 Series Central Nurse Station, Model/Catalog Number: CN-6201 Software Version: software versions:…

    Due to a cybersecurity issue associate with a NULL Pointer Dereferences vulnerabiity. If exploited would potentially cause disruption of the centralized monitoring of multiple beds and the visualization of alarms.

    FDA · DeviceNihon Kohden America LLCUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice →
  6. US
    Drugs & medicalClass II

    Medtronic MiniMed, Inc. recalls Brand Name: MiniMed Flex Product Name: MiniMed Flex Insulin Pump Model/Catalog Numbers: MMT-8062; MMT-8072 Product Description: The…

    Some MiniMed Flex insulin pumps were released with missing (i.e., devices with no result or abort test results are presumed to have failed) or failed verification test results in one or more of 9 functional tests. The…

    FDA · DeviceMedtronic MiniMed, Inc.U.S. Nationwide distribution in the states of AR, AZ, CO, FL, KS, KY, LA, MI,…Official notice →
  7. US
    Drugs & medicalClass II

    Medline Industries, LP recalls Rollator, Bariatric, Basic Steel, Blue, mechanical walker with four legs and a metal frame intended for medical purposes to provide…

    The front fork stem bolt/wheel assembly may disconnect from the rollator frame tubing. If the front fork stem bolt/wheel assembly disconnects from the rollator frame tubing, the front wheels may become loose or detach…

    FDA · DeviceMedline Industries, LPWorldwide distribution - US Nationwide and the country of Canada.Official notice →
See all drugs & medical recalls →