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…
Read the official notice →- Date
- 2023-07-05
- Country
- United States
- Brand
- Tornier
- Product
- AEQUALIS FLEX REVIVE Assembly Screw 0mm Short, Model Number ARS655118
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Australia, Canada,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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…
- 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
- 2023-07-05
- US
DRE Medical Group Inc recalls Philips Respironics V60 Ventilator-Intended to mechanically control or assist patient breathing by delivering a predetermined percentage…
Devices were imported with Japanese Language and NIST Oxygen Gas Fittings and retrofitted, may pose a serious health risk as the gas pathway of these devices may be contaminated.
- US
Luminex Corporation recalls VERIGENE Clostridium difficile Nucleic Acid Test, REF 30-002-022
It is possible that in rare instances the VERIGENE CDF Nucleic Acid Test Kit (Part No. 20-005-022) and the VERIGENE Enteric Pathogens Nucleic Acid Test Kit (Part No. 20-005-023) could provide a false-negative result…
- US
Randox Laboratories Ltd. recalls Immunoassay Premium Level 3-In vitro diagnostic use, as assayed quality control material to monitor the accuracy and reproducibility of…
Delay in reporting results due to Quality Controls running high outside of range. Target value and range for ACTH in Immunoassay Premium Level 3, IA2640, lot 2031EC and Immunoassay Premium Control Tri Level kit batch…
- US
Limacorporate S.p.A recalls REF 1975.14.800, Prima TT Genoid Modular Reverse TT Baseplate, Sterile R
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
FDA · DeviceLimacorporate S.p.AUS Nationwide distribution in the states of MI, IL, ND, MO, OK.Official notice → - US
Covidien, LLC recalls Medtronic ILLUMISITE Platform Console, Model Number ILS-1000-CS
Single ILLUMISITE Platform Console was converted from a 220-240VAC model to a 120VAC configuration using a non-supplied power cord and non-supplied fuses in the field by Medtronic Field Service Engineer.
- US
Baxter Healthcare Corporation recalls NaviCare Patient Safety V3.9.200 to 3.9.600, used with the Centrella Bed
Baxter identified a potential risk where the "safety" monitoring and "bed exit" monitoring features may enter a permanent state of alert suppression. In this state, a caregiver may not be alerted remotely when assigned…
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of OR, SC, VA, TN, GA, NC, CO, NC, FL.Official notice →