Howmedica Osteonics Corp. recalls Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
The Exeter V40 Trial Head, catalog number 6364-8-026 (size 26mm, -3) may appear green, when it is meant to be a blue color. Green signifies a size 26mm, +3 Trial Head.
Read the official notice →- Date
- 2023-06-21
- Country
- United States
- Brand
- Howmedica Osteonics
- Product
- Exeter V40 Trial Head, 26mm, -3, Catalog Number 6364-8-026
- Classification
- Class II
- Units
- International distribution in the country of Ireland.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-03-13
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 →- 2024-02-07
US
Howmedica Osteonics Corp. recalls Scorpio-Flex Ttl Kn P-S Tib Brg Insrt Asy- -Intended for knee replacement Part Number: 72-16-0910
Product manufactured using UHMWPE raw material over 5 years of age has the potential for elevated levels of oxidation. Oxidation within UHMWPE can have an impact on its material properties.
FDA · DeviceHowmedica Osteonics Corp.Nationwide Foreign: Argentina, Australia, Brazil, Canada, Chile, China,…Official notice →- 2023-06-07
US
Howmedica Osteonics Corp. recalls TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM Intended for knee replacement Catalog Number: 5532-G-413-E
Mislabeled:Labeled Catalog Number: 5531-G-312-E, TRIATHLON X3 TIBIAL BEARING INSERT CS #3 12MM, may contain Catalog Number: 5532-G-413-E, TRIATHLON X3 TIBIAL BEARING INSERT PS #4 13MM, and vice versa
FDA · DeviceHowmedica Osteonics Corp.US Nationwide - Worldwide Distribution: CT, FL, IN, KY, MT, NJ, OR, PA, SC…Official notice →- 2023-04-19
US
Howmedica Osteonics Corp. recalls stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
FDA · DeviceHowmedica Osteonics Corp.U.S., Netherlands, Japan, China, India, Korea, and Australia.Official notice →US
Howmedica Osteonics Corp. recalls stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
FDA · DeviceHowmedica Osteonics Corp.U.S., Netherlands, Japan, China, India, Korea, and Australia.Official notice →
Other drugs & medical recalls in the United States
- 2023-06-21
US
LumiraDx recalls SteriPack Sterile Polyester Spun Swabs (25 units/Pack)- Intended for sample collection in the intended nasal area. Catalog Number: 60566RevB
Fails Post-Sterilization Sterile Swabs Cantilever (Bend) Testing and may be more susceptible to breakage. If the swab breaks in the nasal cavity of a patient may cause injury or medical intervention to remove part of…
US
Galt Medical Corporation recalls Tearaway Introducer Kit, REF: KIT-010-12, KIT-010-17, KIT-900-16
Sheath introducer assemblies could potentially, due to improper storage conditions, have a luer connection portion of the dilator hub that cracks or dislodges during use, which renders the dilator component unusable,…
FDA · DeviceGalt Medical CorporationWorldwide - US Nationwide distribution in the states of PA, UT, FL, PA, OH,…Official notice →US
Vyaire Medical recalls bellavista 1000e Ventilator, Catalogue Number 301.100.130; Continuous Use Ventilator
Vyaire Medical identified two patient safety risks during the use of the bellavista 1000 and bellavista 1000e: 1. Under certain conditions of use, the touchscreen may become unresponsive and the device application…
US
Merit Medical Systems, Inc. recalls Aspira Pleural Drainage Catheter Insertion Tray 15.5F, REF: 4992509, Version A, Sterile EO, Rx Only
There is a potential that valve assemblies will not open. preventing fluid from draining.
FDA · DeviceMerit Medical Systems, Inc.Worldwide - US Nationwide distribution in the states of AK, AL, AR, AZ, CA,…Official notice →US
Datascope Corp. recalls Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Model Number 0998-00-0800-55, Part Number 0998-00-0800-XX
The digital IFUs provided with the Cardiosave IABP during the software update to version D.00 incorrectly annotated compliance to standard 60601-1-12:2014 within the updated IFU.
US
Ossur H / F recalls Icelock 125 Ratchet, REF: L-125000; Icelock 600XM Ratchet, REF: L-621200; Icelock 621 Ratchet, REF: L-621000; Icelock 621 Ratchet Adaption…
A mechanical lock used to connect and release a locking liner into a prosthetic socket have an attachment pin and lock that can wear down faster than expected, leading to the potential for the pin to disengage from the…
FDA · DeviceOssur H / FUS: SC, FL,NM, PA, VA, CA, TX, MT, UT, OH, NV, KS, MI, GA, IA, WA, TN, AZ, MN,…Official notice →