Smith & 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
Read the official notice →- Date
- 2024-09-18
- Country
- United States
- Brand
- Smith & Nephew
- Product
- ROTATION MEDICAL TENDON STAPLES (8) (narrow indication)-Intended for fixation of prosthetic material to soft tissues. Product Number:…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Australia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-11-06
USSmith & 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 → - 2024-09-25
- US
Smith & Nephew, Inc. recalls DIAMOND POINT, BOTH ENDS K-WIRE, REF 128042, metallic bone fixation fastener
Smith & Nephew, Inc., has initiated a field action to voluntarily remove two batches of K-Wires due to a packaging error. A complaint was received indicating that a package contained K-WIRE .062X9 2PT DM wires instead…
- 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 → - 2023-09-27
- 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.
Other drugs & medical recalls in the United States
- 2024-09-18
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline convenience kits containing semi-rigid suction liners labeled as follows: MTHZ GYN LAPAROSCOPY, Pack Number DYNJ909739
Due to reported adverse events, Medline Industries, LP. is issuing a recall on specific SKUs and lots of 1500 cc semi-rigid liners manufactured from 09/2023-11/2023 due to the potential loss of suction or low suction…
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution - US Nationwide and the countries of Canada, Panama.Official notice → - US
Siemens Healthcare Diagnostics, Inc. recalls Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9 tumor-associated…
Positive bias for some samples around the CA 19-9 upper limit of normal of 35 U/m as compared to the previous lot. The sample bias observed was greatest in the Asia Pacific sample population. The observed bias is not…
FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide - US Nationwide distributionOfficial notice → - US
Zoe Medical Incorporated recalls Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330
This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.
- US
MEDLINE INDUSTRIES, LP - Northfield recalls Medline ReNewal Reprocessed Covidien LigaSure Maryland Jaw Sealer/Divider, Nano-Coated, Compatible w/ FT10 37 cm FT10 SW…
Potential for an incomplete seal on the packaging tray.
- US
Ion Beam Applications S.A. recalls IBA Proton Therapy System - PROTEUS 235 ProteusPLUS and ProteusONE Software versions: PTS-8 versions, PTS-10 versions, PTS-11…
Safety Parameters Verification Mechanisms can be deactivated in clinical runtime
FDA · DeviceIon Beam Applications S.A.Worldwide - US Nationwide distribution in the states of AK, NJ, PA, VA,OK,FL,…Official notice → - US
Smiths Medical ASD Inc. recalls smiths medical portex BLUselect, tracheostomy tube, labeled as follows: 1) BLUSELECT 6.0, CUFFED, NON-FEN, 10/BX, Item Number…
There is the potential for a disconnection of the pilot balloon from the tracheostomy inflation line within specific lots of the BLUSelect, BLUgriggs and BLUperc products due to a manufacturing defect.