Smith & Nephew Inc recalls LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.
Read the official notice →- Date
- 2022-05-25
- Country
- United States
- Brand
- Smith & Nephew
- Product
- LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution in the states of CT, NC,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Smith & Nephew recalls
- 2023-06-07
USSmith & Nephew, Inc. recalls Smith&Nephew ENGAGE Cementless Partial Knee System, Tibial Anchor Stem, Part Numbers: a) REF 1-10011-100 (SIZE 1-2), b) REF 1-10011-200…
Recent complaint data indicates that the revision rate may be trending higher than corresponding similar devices in global joint replacement registries. The data identifies a potential signal that the performance is an…
- 2023-04-26
- US
Smith & Nephew, Inc. recalls JOURNEY II UNI XLPE TIBIA INSERT MEDIAL SZ 7-8 8MM
A mispack occurred during the manufacturing process, resulting in the box incorrectly containing JOURNEY II UNI Tibia Insert Medical Size 1-2 12MM instead of the JOURNEY II UNI Tibia Insert Medial Size 7-8 8MM.
FDA · DeviceSmith & Nephew, Inc.US Nationwide distribution in the states of IL, MD, MI, MS, NY, OH, TX, VA, WA.Official notice → - 2022-07-27
- US
Smith & Nephew, Inc. recalls (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left,…
The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.
FDA · DeviceSmith & Nephew, Inc.US Nationwide distribution in the states of AZ, CA, GA, KS, LA, MN, MI, MO,…Official notice → - 2022-02-16
- US
Smith & Nephew, Inc. recalls Acufex Access Advanced Positioning Kit - indicated for use to position and distract the extremity of patient during open and arthroscopic…
Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process
FDA · DeviceSmith & Nephew, Inc.Worldwide distribution - US Nationwide distribution in the states of CO, CT,…Official notice → - 2022-02-09
- US
Smith & Nephew, Inc. recalls INTEGRA SURFIX ALPHA Screwdriver Torx 10, REF 219 135 ND
The affected screwdrivers are out of specification and may not mate with the Surfix Alpha Lock screw
FDA · DeviceSmith & Nephew, Inc.US Nationwide distribution in the states of CA and OH.Official notice → - 2021-12-22
- US
Smith & Nephew, Inc. recalls smith&Nephew EVOS MEDIAL DISTAL FEMUR PLATE, L, 5H, 90MM, REF 72573101
Testing vendor notified Smith & Nephew that previous MRI scanning conditions provided in Exponents reports were erroneous. Erroneous data from the reports was incorporated in the released IFU 81110294 EVOS Large…
FDA · DeviceSmith & Nephew, Inc.US Nationwide distribution in the states of CO, FL, GA, MA, MN, MO, NC, NJ,…Official notice →
Other drugs & medical recalls in the United States
- 2022-05-25
- US
Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit
Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.
- US
Windstone Medical Packaging, Inc. recalls Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack…
Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International, that are subject to a drug recall due to uncertainty of the adequacy of the validation of the…
- US
Clinician's Choice Dental Products Inc. recalls Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via…
Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK
- US
Randox Laboratories Ltd. recalls CK MB Calibrator, Catalogue Number CK2393
Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient Samples.
FDA · DeviceRandox Laboratories Ltd.Domestic distribution to WV and PR. International distribution to Bangladesh,…Official notice → - US
Bio-Rad Laboratories, Inc. recalls BioPlex 2200 REF 12000670 ToRC IgM Reagent Pack
Performance concerns for the CMV IgM analyte. Analyte has demonstrated variable elevated background depending on the handling of the reagent pack.
FDA · DeviceBio-Rad Laboratories, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AR, AZ,…Official notice → - US
Abbott Vascular recalls Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO
There is a potential that the proximal marker may separate from the imaging catheter
FDA · DeviceAbbott VascularUS:AL AR AZ CA CO CT DC FL GA HI IA IL IN KS KY MA MD ME MI MN MO MT NC NE NH…Official notice →