Tornier, Inc recalls stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into…
Read the official notice →- Date
- 2023-10-25
- Country
- United States
- Brand
- Tornier
- Product
- stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502
- Classification
- Class II
- Units
- US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Tornier recalls
- 2024-10-09
USTornier, Inc recalls Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty
Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.
- 2024-09-25
- US
Tornier, Inc recalls stryker TORNIER PERFORM HUMERAL SYSTEM - STEMLESS US Anatomic Nucleus, REF DWM003A; anatomic total arthroplasty of the shoulder
One lot of Perform Humeral Nucleus may exceed the specification for bacterial endotoxin load (max 20 EU/device).
FDA · DeviceTornier, IncUS Nationwide distribution in the states of IL, WI, AZ, NV, SD.Official notice → - 2024-05-29
- US
Tornier S.A.S. recalls Stryker Blueprint Software, Catalog #BPUE001.
The software bug allows for case planning with anatomic glenoid Perform / Perform Augmented implants and anatomic humeral Tornier Flex implant configurations that are incompatible and do not have regulatory approval.
FDA · DeviceTornier S.A.S.US Nationwide distribution in the states of FL, KY, NJ, and WI.Official notice → - 2024-01-31
- US
Tornier, Inc recalls Stryker Tornier Perform Reversed Glenoid Press-Fit Short Post Ti6AI4V, REF DWJ001, L: 7mm, Cementless Sterile.
The incorrect device is contained in the labeled package.
FDA · DeviceTornier, IncDistribution was made to AR, AZ, CA, CO, CT, NC, OH, TN, and VA. There was no…Official notice → - 2023-07-05
- US
Tornier, Inc recalls AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
A comingle/swap resulted in the labeling and laser marking on the product to state it is a Aequalis Flex Revive Assembly Screw 0mm Standard (ARS655101) but it was a Aequalis Flex Revive Assembly Screw 0mm Short…
FDA · DeviceTornier, IncWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice → - 2022-06-08
- US
Tornier, Inc recalls Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
The device is unable to meet sterilization requirements when sterilized per instructions in an Aesculap container.
Other drugs & medical recalls in the United States
- 2023-10-25
- US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE ReNewal Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/ GEN11 SW v2018-1 and Lower, REF HARH45R. surgical…
Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.
- US
DeRoyal Industries Inc recalls DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit
DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due…
- US
Access Vascular, Inc recalls HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
Specific lots of the Dual Lumen HydroPICC Kits were provided with the incorrect revision of the Instructions For Use (IFU) which do not include the following warnings statement: HydroPICC Dual Lumen Catheter is for…
FDA · DeviceAccess Vascular, IncUS Nationwide distribution in the states of IL, TX.Official notice → - US
Cardinal Health 200, LLC recalls Monoject(TM) 1 mL Tuberculin Syringe Luer-Lock Tip Soft Pack, Model Number/Product Code: 1180100777
Syringe contains conical tip that is not compatible with certain needleless IV connector(s).
FDA · DeviceCardinal Health 200, LLCNationwide distribution to AK, AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL,…Official notice → - US
EITAN MEDICAL LTD recalls Sapphire Infusion Pumps, Models: Multi-Therapy (REF 15031-000-0028), Epidural (REF 15032-000-0027) and SapphirePlus (REF 15038-000-0001)
Infusion Pumps with affected software revision may fail to detect air in line, which may lead to air embolism.
- US
Olympus Corporation of the Americas recalls Olympus High-Flow Insufflation Unit, Model UHI-4. For laparoscopic surgery.
There have been reports of patients suffering arrhythmias, reported as short cardiac arrests, during surgical procedures where UHI-4s were used. These events may have been due to an over insufflation of the abdominal…