Smith & Nephew Inc recalls smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
The firm conducting a recall due to a complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 4N LT implant instead of a LEGION NARROW PSvOXIN SZ 5N LT as described on the product label.
Read the official notice →- Date
- 2023-09-27
- Country
- United States
- Brand
- Smith & Nephew
- Product
- smith&nephew LEGION OXINUM POSTERIOR STABILIZED NONPOROUS FERMOAL COMPONENT, SIZE 5N, LEFT, NARROW, REF 71421265; knee joint
- Classification
- Class II
- Units
- OH, CT, TX, NC, CA, NE, NV
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-09-18
USSmith & Nephew Inc. recalls ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number:…
Product packaging process may result in an improper or incomplete seal of the outer foil pouch surrounding the inner Tyvek pouch, compromising product sterility
FDA · DeviceSmith & Nephew Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice →- 2024-06-05
- US
Smith & Nephew Inc recalls smith&nephew OXINIUM Femoral Head 12/14 Taper, REF 71343204, 32 MM OD +4, Sterile; and smith&nephew, 12/14 Taper, REF 71343604, 36 MM M / +4
Packaging contained the incorrect size of femoral head from what was displayed on the label.
FDA · DeviceSmith & Nephew IncInternational distribution to the countries of Australia, Germany, Japan,…Official notice → - 2023-11-01
- US
Smith & Nephew, Inc. recalls JOURNEY II BCS CONSTRAINED ARTICULAR INSERT Size 5-6, 10 MM Left, REF 74029262; knee prosthesis
The JRNY II BCS XLPE ART ISRT SZ 5-6 LT 10MM was laser etched, labeled and packaged as a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM. And also, a JRNY II BCS CNSTRD ART ISRT 5-6 LT 10MM was laser etched, labeled and…
FDA · DeviceSmith & Nephew, Inc.Worldwide distribution - US Nationwide and the country of Japan.Official notice → - 2023-08-30
- US
Smith & Nephew, Inc. recalls TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE LEFT, REF 71647336, Femur nail
A complaint was received indicating that a package contained a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 40CM 130 DEGREE LEFT implant instead of a TRIGEN TROCHANTERIC ANTEGRADE NAIL LIME 11.5MM X 36CM 130 DEGREE…
- 2023-06-07
- US
Smith & 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 →
Other drugs & medical recalls in the United States
- 2023-09-27
- US
Remote Diagnostic Technologies Ltd. recalls Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, and 00-1007, when Used With…
Full screen error message may occur on patient monitors with affected hardware version, either during or after laryngoscopes are unplugged from monitors, informing users a 60-100 second shutdown/restart are required.…
FDA · DeviceRemote Diagnostic Technologies Ltd.US:AZ, AL, CA, CO, DC, DE, FL , GA, HI, IA, ID, IL, IN , KS, KY, MA , MD , ME,…Official notice → - US
Ortho-Clinical Diagnostics, INc. recalls VITROS XT Chemistry Products ALKP Slides
Samples containing high levels of ALKP (or an interfering substance) could deplete the available substrate in the reagent layer of a VITROS ALKP Slide and not post the substrate deleption (DP) code, which may result in…
FDA · DeviceOrtho-Clinical Diagnostics, INc.Worldwide Distribution: US (nationwide) and OUS (foreign) distribution to…Official notice → - US
Avanos Medical, Inc. recalls COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be…
Avanos has received an increase in complaints from customers for COOLIEF RF Generators producing F100 and F101 faults.
FDA · DeviceAvanos Medical, Inc.US Distribution to states of: AZ, CA, GA, IA, IN, KS, LA, MN, NC, NM, NY, OH,…Official notice → - US
Copan Diagnostics Inc recalls COPAN REF: 2U045S01 300uL Transfer Pipette Individually wrapped pipettes, 1000 pcs.
Due to plastic defects, the pipette aspiration capability potentially doesn't meet the expected tolerance
- US
R A Medical Services recalls MINISCAV (tm) Vacuum Pump
Inadequate documentation of acceptance activity
- US
Insulet Corporation recalls Omnipod 5 Automated Insulin Delivery System
An error message was received when using the Omnipod 5 App on compatible smartphones that prevented phone control users from controlling the Omnipod 5 Automated Insulin Delivery System from their Omnipod 5 App which…