Zimmer, Inc. recalls Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software…
Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peeling seals. Compromised sterile barrier may lead to…
Read the official notice →- Date
- 2026-05-06
- Country
- United States
- Brand
- Zimmer
- Product
- Brand Name: Disposable Mixing Bowls with Spatula Product Name: Mixing Bowl and Spatula Model/Catalog Number: 00-5049-011-00 Software…
- Classification
- Class II
- Units
- US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Zimmer recalls
- 2026-07-01
USZimmer, Inc. recalls Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10…
Firm received a complaint with no clinical impact in which a posterior augment was found within the distal augment package.
FDA · DeviceZimmer, Inc.Refer to the attached ZFA 2026-00088_Initial Consignee List and ZFA…Official notice →- US
Zimmer, Inc. recalls Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
Five complaints have been received identifying issues where the plastic guides were catching during reaming, leading to breakage.
- 2025-12-31
- US
Zimmer, Inc. recalls Brand Name: Affixus Antegrade Femoral Nailing System Product Name: Affixus Antegrade Femoral Nails Model/Catalog Number: 815509420…
Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue…
FDA · DeviceZimmer, Inc.US Nationwide distribution in the states of AL, AZ, CA, FL, IN, KY, MA, MO,…Official notice → - 2025-11-12
- US
Zimmer, Inc. recalls Zimmer Biomet Dual Mobility Vivacit-E Highly Crosslinked Polyethylene, 28 mm I.D., 44 mm O.D., Size F, Bearing, Model/Catalog Number:…
Zimmer Biomet is conducting a medical device recall for two (2) lots of the Dual Mobility Vivacit-E¿ Bearing due to a commingle. The outer package is labeled as a Size F 44 mm, however, the implant inside the package…
FDA · DeviceZimmer, Inc.US: OH, GA, WI, NE, IA, IL, CA, NY, MD, NC, PA, AL, TN, MI, WA, FL, TX, KS,…Official notice → - 2025-04-30
- US
Zimmer, Inc. recalls Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained,…
The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome femoral stems or stainless-steel femoral stems.
FDA · DeviceZimmer, Inc.Worldwide distribution - US Nationwide and the countries of Panama, Hong Kong,…Official notice → - 2025-04-02
- US
Zimmer, Inc. recalls NexGen LPS Flex, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Model Number 00-5962-042-10
The "Use with plate 7, 8, 9, 10" compatibility statement on top of the label does not match with the compatibility statements "USE WITH PLATE 5, 6" in the translations section of the same label.
FDA · DeviceZimmer, Inc.Worldwide - US Nationwide distribution in the states pf CA, KS, MA, MD, ME,…Official notice →
Other drugs & medical recalls in the United States
- 2026-05-06
- US
Hologic, Inc recalls Brand Name: Genius" Review Station Product Name: Genius" Review Station Display (Barco Monitor) Model/Catalog Number: CMP-01669 Software…
It was identified that certain devices were being operated outside the validated and FDA-cleared display configuration due to user modification of the manufacturer-installed settings. Modifications included disabling…
FDA · DeviceHologic, IncWorldwide distribution - US Nationwide and the countries of Asia Pacific,…Official notice → - US
Medtronic, Inc. recalls Medtronic Sphere-9 Catheter, Model Number AFR-00001; catheter, percutaneous, cardiac ablation, for treatment of atrial flutter.
Ventricular fibrillation (VF) occurred during radiofrequency (RF) therapy with the Medtronic Sphere-9 catheter in patients who have a Biotronik Implantable Cardioverter Defibrillator (ICD) or Biotronik Cardiac…
- US
North American Rescue LLC. recalls AIDBAGs are first aid kits of convenience composed of individually labeled devices designed as specialty first aid kits designed for…
Kits contain the McKesson TRUE Metrix PRO Professional Monitoring Blood Glucose System that has been recalled for an issue with the software design of the E-5 Error Code where the meter displays an E-5 error code for a…
- US
Clinical Innovations, LLC recalls Brand Name: Kiwi Omni Vacuum Delivery System Product Name: Kiwi Omni Vacuum Delivery System Model/Catalog Number: VAC-6000MT Product…
Due to complaints of device breakage at the traction force gauge to handle joint.
FDA · DeviceClinical Innovations, LLCWorldwide - U.S. Nationwide distribution including in the states of AK, AR,…Official notice → - US
Milestone S.R.L. recalls VACUUM BAG SU LARGE, Non-sterile specimen container, Model/Catalog Number: 68409SS
There is a possibility of reagent leakage from the specimen container.
FDA · DeviceMilestone S.R.L.Worldwide distribution - US Nationwide and the countries of Canada, Chile,…Official notice → - US
Healthmark Industries Co., Inc. recalls Mesh Style Tip Protectors CSW-03-2.0 Open-end style CSW-04-4.0 Closed-end style
Product does not have FDA clearance.