OmniLife Science recalls OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total…
The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.
Read the official notice →- Date
- 2021-11-24
- Country
- United States
- Brand
- OmniLife Science
- Product
- OMNI K2 Hip Stem, Manufacturer's Product Code 130006 The OMNI K2 Hip Stem is intended for use as the femoral component of a primary total…
- Classification
- Class II
- Units
- US Distribution to states of: Colorado and Virginia.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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.
Other drugs & medical recalls in the United States
- 2021-11-24
US
Medicalplastic S.R.L. recalls Ilizarov Wire Tensioner, Model 71070341, UDI (10)08033201842072(10)21HP02550(11)210831(21E434
Medicalplastic s.r.l. is conducting a voluntary field action to remove a group of Ilizarov Wire Tensioners due to a manufacturing error. An internal washer of the Ilizarov Wire Tensioner has been made in a wrong…
US
Laboratoires Bodycad, Inc. recalls Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable…
There is a risk of breakage of the torque limiting adaptor if used counterclockwise and it must not be used with a power tool due to no test data validating this use.
FDA · DeviceLaboratoires Bodycad, Inc.Distribution was made to CO, MI, and NY. Foreign distribution was made to…Official notice →US
bioMerieux, Inc. recalls API 50 CH, Model 50300
There is potential to provide an incorrect organism identification.
US
Bio-Rad Laboratories, Inc. recalls BIO-RAD BioPlex 2200 REF 12000651 Syphilis Total & RPR Calibrator Set CAL The BioPlex 2200 Syphilis Total & RPR Calibrator Set is…
Due to two issues: 1) Customer complaints associated with greater than expected Rapid Plasma Reagin (RPR) reactivity which does not confirm with treponemal antibody test which may be due to a positive correlation…
FDA · DeviceBio-Rad Laboratories, Inc.Worldwide Distribution: U.S.(nationwide) including states of: AK, AL, AZ, CA,…Official notice →US
Arrow International Inc recalls Arrow-Trerotola Over-The-Wire PTD Kit Percutaneous Thrombolytic Device : 7FR Product Code: PT-65709-W The Arrow-Trerotola" Percutaneous…
7FR Percutaneous Thrombolytic Device (PTD) Inner lumen (orange) detached from the device basket result in embolization and retrieval with an additional intervention and consequent delay of therapy.
FDA · DeviceArrow International IncWorldwide distribution: US (Nationwide) and OUS (Foreign) to countries of: BE…Official notice →US
Beaver Visitec International, Inc. recalls bvi CustomEyes Kit-Lafayette General Medical Center: CustomEyes Cataract Surgical Kits that contain Beaver Xstar Crescent…
Product packaged as Beaver Xstar Crescent Knife, 2.5mm, 55 degrees bevel-down blades contain bevel-up blades
FDA · DeviceBeaver Visitec International, Inc.Nationwide Foreign: Australia Austria France Germany Netherlands Spain Japan…Official notice →