Smith & Nephew, Inc. recalls BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
Removal of affected lot of screws due to labeling error.
Read the official notice →- Date
- 2025-12-24
- Country
- United States
- Brand
- Smith & Nephew
- Product
- BIOSURE HA SCREW, 6MM x 20 MM. Threaded metallic bone fixation fastener.
- Classification
- Class II
- Units
- US (nationwide) distribution to states of : AL, CA, CO, FL, IA, IL, KY, MN,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-06-24
USSmith & Nephew, Inc. recalls TRIGEN PROXIMAL STRAIGHT HUMERAL NAIL 8/7 X 16, REF: 71760816
Humeral nail due to a manufacturing error is missing distal holes and if implanted may lead to revision surgery but, if the missing holes are identified before implantation, an equivalent backup can be used, or a bent…
FDA · DeviceSmith & Nephew, Inc.International distribution to the countries of BE, DE, IT.Official notice →- 2025-05-28
- US
Smith & Nephew, Inc. recalls META-TAN LAG/COMPRESSION SCREW KIT 90MM/85MM, REF: 71642690
Integrated Lag/Compression Screw Kit has a compression screw with hexagon socket that may be undersized, which causes the screw to be non-functional, which would require replacement with another adequate size screw,…
FDA · DeviceSmith & Nephew, Inc.Worldwide - US Nationwide distribution in the states of FL, NH, TX, CA, OH,…Official notice → - 2024-12-11
- US
Smith & Nephew Inc. recalls BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
FDA · DeviceSmith & Nephew Inc.Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY,…Official notice → - 2024-11-13
- US
Smith & Nephew, Inc. recalls Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar…
The Bipolar assembly contains an oversized Retainer Ring.
FDA · DeviceSmith & Nephew, Inc.International distribution to the countries of Australia, Belgium, Canada,…Official notice → - 2024-11-06
- US
Smith & Nephew Inc recalls smith&nephew LEGION OXINIUM POSTERIOR STABILIZED NONPOROUS FEMORAL COMPONENT, SIZE 5N, RIGHT, NARROW, REF 71421275; Uncoated knee femur…
Complaint received indicating that a package contained a LEGION NARROW PS OXIN SZ 5N RIGHT implant instead of a GENESIS II POSTERIOR STABILIZED FEMORAL SIZE 5 LEFT as described on the product label.
FDA · DeviceSmith & Nephew IncUS Distribution to states of: MS, TN, NC, CA, GA, DE, AL, and OUS distribution…Official notice → - US
Smith & Nephew Inc recalls smith&nephew LEIGON OXINIUM CONSTRAINED NONPOROUS FEMORAL COMPONENT, SIZE 4 LEFT, REF 71421164; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL,…
Complaint received indicating that a package contained a LGN OX CONSTRAINED FEM 3 LT implant instead of a LGN OX CONSTRAINED FEM 4 LT as described on the product label.
FDA · DeviceSmith & Nephew IncUS Distribution to state of Texas and OUS (foreign) to countries of: Spain,…Official notice →
Other drugs & medical recalls in the United States
- 2025-12-24
- US
Abbott Laboratories recalls Alinity ci-series System Control Module (SCM), REF: 03R70-01, 03R70-20
Abbott Laboratories is recalling their Alinity ci-series System Control Module, a chemistry/immunoassay anayzer, by correction. The reason for the recall is potential performance issues found in the Alinity ci-series…
FDA · DeviceAbbott LaboratoriesWorldwide distribution: US (nationwide) to states of: AK, AL, AR, AZ, CA, CO,…Official notice → - US
Cepheid recalls Brand Name: Xpert¿ BCR-ABL Ultra Model/Catalog Number: GXBCRABL-10
Invitro diagnostic test kits with specimens that have elevated white blood cell count (>30,000 cell) may cause inaccurate results.
FDA · DeviceCepheidUS: AL AR AZ CA CO FL GA IA IL KS KY LA MD ME MI MN MO NC NE NH NJ NY OH PA RI…Official notice → - US
Medtronic MiniMed, Inc. recalls InPen App, Model/CFN Number: MMT-8061 (Android Users)
When app is uninstalled and reinstalled, insulin pen software issue causes Choose Notification Style Screen to not show during setup so users can't choose to allow notifications to override phone settings when on…
FDA · DeviceMedtronic MiniMed, Inc.US: IL, AZ, MN, NE, KS, TN, CA, FL, TX, WA, MO, NC, NY, WI, IN, ME, CT, RI,…Official notice → - US
Myofunctional Research Company USA recalls Myosa for Kids KS1 REF MyOSAKS1_Sb/Sp/Mb/Mp/Lb/Lc KS2 REF MyOSAKS2_Sb/Sc/Mb/Mc/Mp/Lb/Lc Myosa for Kids is a mouthguard in 3…
Due to firm mistakenly distributing product within the U.S. without FDA premarket clearance/approval.
FDA · DeviceMyofunctional Research Company USAU.S. (nationwide) distribution to states of: Nationwide: AK, AR, CA, CO, FL,…Official notice → - US
Rocket Medical Plc recalls Brand Name: Rocket Product Name: Rocket 16Fg Seldinger Catheter Procedure Tray Model/Catalog Number: R54549-16-PK Software Version: N/A…
IFU and device kit labeling contains misleading statements leading to improper securing of the device resulting in the potential to fall out during use.
FDA · DeviceRocket Medical PlcDomestic: CO, CT, IL, MA, ME, NH, NJ, NM, OH, RI, SC, TX; International: UAE,…Official notice → - US
DSAART LLC recalls Brand Name: AART Calf Implant Product Name: Calf Implant Model/Catalog Number: 502-103 - Calf Implant style 1 size 3 UDI-DI code:…
Due to manufactured products that deviated from established specifications and being distributed without obtaining the required FDA premarket approvals or clearances.
FDA · DeviceDSAART LLCU.S.: AR, AZ, CA, CO, CT, DC, FL, GA, KY, IL, MA, MD, MI, MN, MS, NE, NJ, NY,…Official notice →