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.
Read the official notice →- Date
- 2022-06-08
- Country
- United States
- Brand
- Tornier
- Product
- Ratcheting Screwdriver Handle, provided in the Aequalis Perform Reversed kit
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 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 → - 2023-10-25
- US
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…
- 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 →
Other drugs & medical recalls in the United States
- 2022-06-08
- US
Medtronic Xomed, Inc. recalls NIM Vital Patient Interface 4.0 (P/N: NIM4CPB1) NIM with Software version 1.3.2
Software anomaly was identified.
FDA · DeviceMedtronic Xomed, Inc.Worldwide distribution - US Nationwide distribution in the states of TX, CO,…Official notice → - US
Dynex Technologies, Inc. recalls DYNEX Agility, Agility Analyzer, Model No. 67000
Control samples aspirated from wrong SmartKit on the Agility. Agility software was updated to v1.4.7 to resolve the issue. This leads to a risk that a control from another assay's SmartKit will be used instead of the…
FDA · DeviceDynex Technologies, Inc.Worldwide distribution - US Nationwide distribution in the states of AL, CA,…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE Polyurethane Foam Bedside Cleaning Kit, REF DYK500FS
Sporadic reports were received of discoloration on the foam sponge on certain lots of the product, which has been identified as microbial contamination.
- US
Becton, Dickinson and Company, BD Biosciences recalls BD Anti-Kappa PE (Cat. No. 346587) is an analyte specific reagent for the Anti-Kappa antibody, which specifically…
Anti-Kappa APC & Anti-Kappa PE analyte reagents may exhibit uncharacteristic flow profiles.
FDA · DeviceBecton, Dickinson and Company, BD BiosciencesWorldwide distribution - US Nationwide distribution in the states of AL, CA,…Official notice → - US
Abbott recalls FIRMap" Catheter, 60mm Basket
Incorrect product labeling.
- US
XVIVO PERFUSION AB recalls XVIVO Organ Chamber REF 19020
The weld seal of the primary pouch was incomplete, and the sterility of the product cannot be ensured/guaranteed.
FDA · DeviceXVIVO PERFUSION ABU.S.: CA, FL, MA, NC, NY, OH, PA, and TX O.U.S.: Austria, Canada, France,…Official notice →