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…
Read the official notice →- Date
- 2023-06-07
- Country
- United States
- Brand
- Smith & Nephew
- Product
- 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…
- Classification
- Class II
- Units
- US Nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-11-01
USSmith & 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 →- 2023-09-27
- US
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.
- 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…
- 2023-04-26
- 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 → - 2022-05-25
- US
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.
FDA · DeviceSmith & Nephew IncWorldwide distribution - US Nationwide distribution in the states of CT, NC,…Official notice →
Other drugs & medical recalls in the United States
- 2023-06-14
- US
Viatris Inc recalls Levsin injection (hyoscyamine sulfate injection, USP), 0.5 mg per ml in water for Injection, 1 ml Ampule (Box of 5 ampules), Rx Only,…
CGMP Deviations: Discontinuation of the Quality program by manufacturer that would assure product meet the identity, strength, quality, and purity characteristics that they are purported or represented to possess.
FDA · DrugViatris IncProduct was distributed to 10 distributors who may have further distribute the…Official notice → - US
Empower Clinic Services LLC dba Empower Pharmacy recalls ASCORBIC ACID PRESERVED INJECTION SOLUTION, 500 mg/mL, 30 mL Sterile Multiple-Dose Vial, RX ONLY, Compounded…
Mislabeling: preservative free product labeled as preserved.
FDA · DrugEmpower Clinic Services LLC dba Empower PharmacyDistributed Nationwide in the USAOfficial notice → - 2023-06-07
- US
Linkbio Corp. recalls LINK SymphoKnee System L-Shaped Femoral Augment, Medial-Right/Lateral-Left, Sz 5-6 Tilastan, cemented. Intended for primary and revision…
Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).
- US
NRT X-RAY A/S recalls Intelli-C, Left side suspended Tabletop, REF: 03400010
There is a potential that the drive shaft in the detector up/down (IDE) movement of the X-Ray machine may break which causes the detector to move until it is stopped by the movement end-stop.
FDA · DeviceNRT X-RAY A/SUS Nationwide distribution in the states of OH, NC, KY, SC, IA, MA, WA, LA,…Official notice → - US
Elekta, Inc. recalls Elekta Medical Linear Accelerator (ELMA) included in the below platforms: a. Elekta Infinity; b. Versa HD; c. Elekta Synergy
A component within a limited number of Elekta Linacs has been realized to be non-compliant to IEC 60601
FDA · DeviceElekta, Inc.Worldwide distribution. US distribution to AR, IN, LA, OK, TN, VA, WA.…Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products Calibrator Kit 11 VANC Reagent Generation (GEN) 50 with affected Assay Data Disk (ADD) for Data…
Unavailable to calibrate VITROS Chemistry Products VANC Reagent, Generation (GEN) 50, results in delay of testing
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Nationwide Foreign: Brazil, Chile, ColombiaOfficial notice →