United Orthopedic Corporation recalls USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm,…
Their is a potential that the implant curved stem may be oriented incorrectly.
Read the official notice →- Date
- 2024-03-06
- Country
- United States
- Brand
- United Orthopedic
- Product
- USTAR II Knee System : Cemented Curved Stem, RHS Ti Plasma Spray, Reference Numbers: REF: PE25153109 - PE25151109 - 9x125mm, PE25151111 -…
- Classification
- Class II
- Units
- US: CA,KY, MI, IN, TN, CO, FL, TX, NV, OUS: Switzerland, United Kingdom,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 United Orthopedic recalls
- 2026-08-12
USUnited Orthopedic Corp. recalls Brand Name: U2 Total Knee System Product Name: Femoral offset bushing, 0mm and 4mm Model/Catalog Number: 9323-5310 Software Version: N/A…
Due to a design issue causing the incorrect engraved numbering on implant that could result in the incorrect orientation of the implant.
FDA · DeviceUnited Orthopedic Corp.US Nationwide distribution in the states of Texas and Michigan.Official notice →- US
United Orthopedic Corp. recalls Brand Name: U2 Total Knee System Product Name: Femoral valgus adaptor, left and right Model/Catalog Number: 9323-5333 and 9323-5334…
Due to an incomplete process of the component screw by a subcontractor which prevents the properly assembling of stem trail.
FDA · DeviceUnited Orthopedic Corp.US Nationwide distribution in the states of Texas and Michigan.Official notice →
Other drugs & medical recalls in the United States
- 2024-03-13
- US
Contract Pharmaceuticals Limited Canada recalls Clindamycin Phosphate, Topical Solution USP, 1%, 60 mL, Rx Only, Manufactured for and Distributed by: Marlex…
Defective Container: Out of specification for weight due to a slow leakage at the 12-month stability timepoint.
FDA · DrugContract Pharmaceuticals Limited CanadaNationwide in the U.S. and Puerto RicoOfficial notice → - 2024-03-06
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK BiMobile Dual Mobility System E-Poly Liner for 28mm Head, 70mm Shell- Indicated for patients with mobility-limiting…
Mislabeled: Packaging incorrectly reflects a MobileLink Dual Mobility insert type F when it should reference G may cause a delay in surgery
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Worldwide - US Nationwide distribution in the states of IL, IN, FL, WA and the…Official notice → - US
Acumed LLC recalls Acu-Loc and Acu-Loc 2 bone plates, screws and accessories for the following REF: 70-0045 Acu-Loc VDU Plate Standard, Left; 70-0045-S…
Distribution without Pre-Market Clearance
FDA · DeviceAcumed LLCWorldwide distribution - US Nationwide and the countries of AE, AR, AU, BE,…Official notice → - US
Olympus Corporation of the Americas recalls Colonoscope, Model Number PCF-H190DL.
Specific repaired colonovideoscopes were assembled without an adhesive which protects them from certain physical conditions such as high levels of vibration, fluctuation in temperature or severe shock loads.
- US
Parker Laboratories, Inc. recalls Tensive Conductive Adhesive Gel, Product Ref. 22-60. 12, 1 case contains 12 inner boxes with 50g tubes packaged in each.
Five complaints were received related to viscosity of Tensive Conductive Adhesive Gel Ref 22-60.
FDA · DeviceParker Laboratories, Inc.US (Domestic): AZ, CA, FL, NC, NJ, NV, NY, PA, WA, WI. OUS (Foreign): Canada,…Official notice → - US
Integra LifeSciences Corp. recalls Ref No: INS5HND / Integra Cranial access kit (without Prep solutions) Bit and Guard. For access to the subarachnoid space or the…
A defect in the sterile packaging (header bag) of the Cranial Access Kit failing the required packaging integrity testing criteria. Therefore, product sterility maybe compromised.
FDA · DeviceIntegra LifeSciences Corp.Worldwide distribution - US Nationwide and the countries of Austria, Bahamas,…Official notice →