Zimmer, 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.
Read the official notice →- Date
- 2026-07-01
- Country
- United States
- Brand
- Zimmer
- Product
- Brand Name: Persona Revision Product Name: Persona Revision¿ Trabecular Metal¿ Femoral Distal Augment Model/Catalog Number: 42-5572-066-10…
- Classification
- Class II
- Units
- Refer to the attached ZFA 2026-00088_Initial Consignee List and ZFA…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 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.
- 2026-05-06
- US
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…
FDA · DeviceZimmer, Inc.US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, FL,…Official notice → - 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
- 2026-07-01
- US
Medline Industries, LP recalls Convenience kits containing select SKUs of 10mL Polycarbonate Colored Syringes. CATARACT FULL BODY DYNJ85743 MAJOR VASCULAR PACK…
Firm identified unapproved design changes to the products outside of the 510(k) cleared by the FDA. Products not initially reported in RES 98601.
FDA · DeviceMedline Industries, LPUS Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice → - US
Boston Scientific Corporation recalls Intera Oncology INTERA 3000 Hepatic Artery Infusion Pump, AP-0300H, implantable drug delivery device
There is the potential for leakage along the drug pathway from the pump through the end of the catheter.
FDA · DeviceBoston Scientific CorporationUS Nationwide distribution in the state of OH.Official notice → - US
Philips North America Llc recalls Philips Telemetry Monitor 5500 1.4 GHz. Model Number: 867232. Includes the following system descriptions: TELE Monitor 5500, 1.4 Ghz,…
Potential for device reset to default "NEW_DEVICE" state, which may lead to a to loss of device configuration and the equipment label, resulting in a failure to reconnect to the PIC iX central monitoring system.
FDA · DevicePhilips North America LlcUS Nationwide distribution in the states of AZ, CA, CO, IN, MA, MI, MN, PA,…Official notice → - US
Medtronic Perfusion Systems recalls Octopus Evolution AS Tissue Stabilizer, Model TS2500
During the manufacturing process, Medtronic personnel identified an assembly issue where the tubing was incorrectly positioned. The short tube was attached to the bottom of the canister, and the long tube was attached…
- US
Dexcom, Inc. recalls Brand Name: Dexcom G7 Continuous Glucose Monitoring System Product Name: Dexcom G7 US Retail Sensor/Transmitter 1-pack Model/Catalog…
Certain lots of Dexcom G7 sensors originally designated as scrap and intended for destruction were stolen during the destruction process. The sensors were later sold to pharmacies and distributors by Pharmsource, LLC.…
FDA · DeviceDexcom, Inc.Dexcom does not have distribution records for this product due to its…Official notice → - US
SURGIFY MEDICAL OY recalls Surgify Halo, 5.4 mm, Medium, Model/Catalog Number: 54.085.SHD.H1; burrs, trephines & accessories (simple, powered)
Potential for burr breakage, occurring during bi-portal endoscopic spinal surgery (BESS).
FDA · DeviceSURGIFY MEDICAL OYUS Nationwide distribution in the states of MN, MA, IN, LA, CA, NY, FL.Official notice →