Limacorporate S.p.A recalls PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Read the official notice →- Date
- 2025-07-02
- Country
- United States
- Brand
- Limacorporate S.p.A
- Product
- PRIMA 4MM ECCENTRICAL ADAPTOR WITH SCREW, REF:1367.15.704, Sterile
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of VA, FL, SC, MS, NY, 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Limacorporate S.p.A recalls
- 2025-01-01
US
Limacorporate S.p.A recalls TEMA Elbow - Axle Small REF 1590.15.010 TEMA Elbow - Axle Large REF 1590.15.020 TEMA Elbow System is a cemented total elbow prosthesis.
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
- 2024-01-24
US
Limacorporate S.p.A recalls PRIMA TT Glenoid Monoblock/Modular reverse TT baseplates: Description/Product Code: BASEPLATE D.25MM REGULAR/1975.14.500, BASEPLATE D.28MM…
Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position.
- 2023-12-20
US
Limacorporate S.p.A recalls PHYSICA HPS Tibial Liner #6 H10 REF 6539.54.610
Due to incorrect product labeling
- 2023-07-05
US
Limacorporate S.p.A recalls REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
FDA · DeviceLimacorporate S.p.AUS Nationwide distribution in the states of MI, IL, ND, MO, OK.Official notice →- 2023-04-05
US
Limacorporate S.p.A recalls SMR TT Hybrid glenoid Std - Peg S, REF: 1379.59.210
Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be…
- 2023-03-22
US
Limacorporate S.p.A recalls TEMA Axle Small, REF 1590.15.010 (additional information is pending receipt of the firm's product label/labeling)
Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
Other drugs & medical recalls in the United States
- 2025-07-02
US
Beckman Coulter Inc. recalls REMISOL Advance UDI-DI code: 13700962601874 All Software Versions: B92487; B92488; C24317; C28652; C37500; D04164; C44703; C57017; C69412;…
Due to a software issue, the software may incorrectly process the date of birth (DoB) received from the Laboratory Information System (LIS) and when the DoB is set to 01/01/1900 or left empty, REMISOL Advance may…
FDA · DeviceBeckman Coulter Inc.Worldwide - U.S. Nationwide distribution including in the states of AK, AL,AR,…Official notice →US
Siemens Healthcare Diagnostics, Inc. recalls Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
Contamination of the diluent by sodium hypochlorite (NaOCl) which may impact calibrator, quality control (QC), and patient results for all assays except for sodium, potassium, and chloride.
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Bahamas.Official notice →US
Jewel Precision Sheet Metal & Machining Co, Inc. recalls Jewel Precision Reusable Rigid Sterilization Container System. Model/Catalog Number: JP-24-6.
The Instructions for Use do not match the 510(k) FDA cleared indications for use or sterility shelf life.
FDA · DeviceJewel Precision Sheet Metal & Machining Co, Inc.US Nationwide distribution in the states of IN, NY, PA.Official notice →US
Becton Dickinson & Co. recalls BD BACTEC MGIT 960 PZA Kit. IVD qualitative procedure for susceptibility testing of Mycobacterium tuberculosis, from culture to…
BD has received additional complaints of intermittent false resistance results for PZA during susceptibility testing of Mycobacterium tuberculosis isolates.
FDA · DeviceBecton Dickinson & Co.Worldwide distribution - US Nationwide and the countries of AR, AU, BD, BE,…Official notice →US
Terumo Cardiovascular Systems Corporation recalls CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial…
Due to an error in assembly of the thermistor within some units, the affected probes will experience inaccuracy in measured shunt sensor temperature. Additionally, following changes in patient temperature without an in…
FDA · DeviceTerumo Cardiovascular Systems CorporationUS Nationwide distribution in the states of California, Delaware, Hawaii,…Official notice →US
CareFusion 303, Inc. recalls Product Name [REF]: Supply Server, CCE Enterprise SW Site License (2-5), BD Pyxis Logistics [806], BD Pyxis MedStation 4000 Main…
During automated dispensing cabinet upgrade/installation/reimaging, component manager was left in installed mode, and if a Microsoft patch is then installed this may lead to an error preventing user access to the…
FDA · DeviceCareFusion 303, Inc.Worldwide - US Nationwide distribution including in the states of PR, DE, GU,…Official notice →