Howmedica Osteonics Corp. recalls Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including…
Read the official notice →- Date
- 2024-06-26
- Country
- United States
- Brand
- Howmedica Osteonics
- Product
- Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Argentina,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Howmedica Osteonics recalls
- 2024-10-16
USHowmedica Osteonics Corp. recalls Triathlon Universal TS Baseplate Size 2 - A single use sterile implantable device intended for cemented applications during primary and…
Anterior locking tabs on the Triathlon Universal Baseplate are out of specification which may prevent engagement of either of the two locking tabs with the locking wire of the tibial insert.
FDA · DeviceHowmedica Osteonics Corp.US Nationwide distribution in the states of AZ, FL, NC, OH, PA, TN, WI.…Official notice →- 2024-09-04
- US
Howmedica Osteonics Corp. recalls Custom Made Device - GMRS EXTENSION Piece 40MM LEFT, 35 Deg EXT Rotated Tabs (Patient Specific); Catalog Number: C-MM100434-00;
A patient specific, custom-made device was supplied for a surgical procedure that did not match the design proposal.
FDA · DeviceHowmedica Osteonics Corp.International distribution to the country of Australia.Official notice → - 2024-07-24
- US
Howmedica Osteonics Corp. recalls UNITRAX Endoprosthesis Head Component - 43mm. Implantable component used in partial hip arthroplasty. Catalog Number: 6942-5-043
Mislabeled: the size on the package label of the UNITRAX¿ Endoprosthesis Head Component potentially may not match the device within the packaging. This product mix only involves the three (3) sizes (43mm, 42mm, and the…
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Australia, Hong…Official notice → - 2024-05-01
- US
Howmedica Osteonics Corp. recalls TRIDENTII PSL CLUSTER58F-Indicated for use in primary and revision patients at high risk of hip dislocation Catalog Number: 742-11-58F
The acetabular shell may have excessive deburring, resulting in a smooth surface on the edge of the shell
FDA · DeviceHowmedica Osteonics Corp.Nationwide Foreign: Netherlands, Canada, Singapore, Spain, Sweden, UKOfficial notice → - 2024-03-13
- US
Howmedica Osteonics Corp. recalls NO 4 TRIATHLON TS PLUS TIB INS X3 POLY 11 MM
Potential packaging breaches of inner blister and outer sterile blister.
FDA · DeviceHowmedica Osteonics Corp.Domestic: Nationwide Distribution; Foreign: Australia, Canada, Chile,…Official notice → - 2024-02-14
- US
Howmedica Osteonics Corp. recalls HRIS ACET CUP CUT TIP 26X140 Part Number: 6210-5-100. single-use, sterile surgical instruments used during hip arthroplasty
Failed to meet the acceptance criteria for the seal integrity and/or package integrity testing for the Sterile Barrier Outer Pouch and the Protective Barrier Inner Pouch, compromising product sterility
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice →
Other drugs & medical recalls in the United States
- 2024-06-26
- US
NxStage Medical Inc recalls NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404,…
The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less…
- US
Exactech, Inc. recalls OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
- US
C.R. Bard Inc recalls Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control…
Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
FDA · DeviceC.R. Bard IncDistribution was nationwide. There was no government/military/foreign…Official notice → - US
Baxter Healthcare Corporation recalls Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent…
There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.
FDA · DeviceBaxter Healthcare CorporationDistribution was made nationwide. There was also government/military…Official notice → - US
Outset Medical, Inc. recalls TabloCart with Prefiltration Drawer PN-0006813, with power cords: PN-0005746 (10-foot), PN-0006578 (15-foot), PN-0005747 (20-foot)10-, 15-…
A cart with prefiltration drawer, an optional hemodialysis system accessory, has a cord with a female connector that has internal contact pins that may become damaged that could create localized heat, sparks, smoke,…
FDA · DeviceOutset Medical, Inc.US Nationwide distribution in the states of FL, CA, NC, GA, MD, DE, AK, OK,…Official notice → - US
Ethicon, Inc. recalls PDS Plus Antibacterial (polydioxanone) Suture - Intended for use in general soft tissue approximation, including use in paediatric…
Issue on a specific packaging machine resulted in a hole in the primary packaging, product sterility compromised and could result in infection .
FDA · DeviceEthicon, Inc.Worldwide distribution - US Nationwide including PR and the countries of AR,…Official notice →