DePuy Orthopaedics, Inc. recalls ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant…
Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical…
Read the official notice →- Date
- 2022-07-27
- Country
- United States
- Brand
- DePuy Orthopaedics
- Product
- ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant…
- Classification
- Class II
- Units
- Nationwide Foreign: Argentina, Australia, Austria, Bahrain, Belgium, Brazil,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 DePuy Orthopaedics recalls
- 2024-04-10
USDePuy Orthopaedics, Inc. recalls ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Product incorrectly labelled.
FDA · DeviceDePuy Orthopaedics, Inc.Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the…Official notice →- 2023-03-29
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DePuy Orthopaedics, Inc. recalls Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to…
FDA · DeviceDePuy Orthopaedics, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Poland,…Official notice → - 2022-07-20
- US
DePuy Orthopaedics, Inc. recalls MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000,…
The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should…
FDA · DeviceDePuy Orthopaedics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - 2022-05-11
- US
DePuy Orthopaedics, Inc. recalls VELYS Robotic-Assisted Solution Base Product No.: 451570100
System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment
FDA · DeviceDePuy Orthopaedics, Inc.Worldwide distribution - US Nationwide and the countries of Israel, Australia…Official notice → - 2022-02-16
- US
DePuy Orthopaedics, Inc. recalls ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product…
May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
FDA · DeviceDePuy Orthopaedics, Inc.US Nationwide distribution in the states of TN, TX.Official notice → - 2022-01-19
- US
DePuy Orthopaedics, Inc. recalls GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
FDA · DeviceDePuy Orthopaedics, Inc.Worldwide distribution - US Nationwide and the countries of Austria,…Official notice →
Other drugs & medical recalls in the United States
- 2022-07-27
- US
Randox Laboratories Ltd. recalls Soluble Transferrin Receptors (STFR), Catalog Number TF10159 (Research Use Only). IVD
A customer reported a problem with the reagent and calibrator. Randox Laboratories carried out an investigation and confirmed the issue. The complaint is pertaining to atypical calibration curves that can results in…
- US
CooperSurgical, Inc. recalls LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English…
FDA · DeviceCooperSurgical, Inc.Domestic: USA AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT,…Official notice → - US
Ambu Inc. recalls Ambu VivaSight 2 DLT; endobronchial tube system used for verifying tube placement and repositioning. Catalog numbers 412351000, 412371000,…
Firm has received complaints on the device concerning leak/rupture of either the bronchial or tracheal cuff. Leakage during procedure could lead to loss of secure airway and will require re-intubation of patient.
FDA · DeviceAmbu Inc.Domestic distribution nationwide. Foreign distribution to Austria, Belgium,…Official notice → - US
Smith & Nephew, Inc. recalls (1) Genesis II Non-Porous Tibial Baseplate Size 5 Right, Product #71420186. (2) Genesis II Non-Porous Tibial Baseplate Size 4 Left,…
The product was mispackaged (swapped). The devices within the inner tray matches the inner tray but does not match the outer box label and the chart sticks.
FDA · DeviceSmith & Nephew, Inc.US Nationwide distribution in the states of AZ, CA, GA, KS, LA, MN, MI, MO,…Official notice → - US
Baxter Healthcare Corporation recalls Hill-Rom PRO+ 36" MRS Surface With X-Ray mattress, REF P7924A01; and REF P7924ARENT01, PRO+ MRS Rental Surface with X-Ray mattress.
The failure mode on the affected mattresses can cause a reduction in the performance of the Microclimate Management feature used to pull heat and moisture away from the patient resulting in an increased patient risk of…
FDA · DeviceBaxter Healthcare CorporationWorldwide distribution - US Nationwide distribution in the states of AZ, CA,…Official notice → - US
Aesculap Implant Systems LLC recalls MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.