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.
Read the official notice →- Date
- 2026-07-01
- Country
- United States
- Brand
- Zimmer
- Product
- Off-Axis Comprehensive Shoulder System, Medium, Augment, Off-Axis, Reamer Guide Model/Catalog Number: 110040241
- Classification
- Class II
- Units
- US Nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 →- 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
GE Medical Systems SCS recalls GE Healthcare AW Server 3.2 ext.6.5; Radiological Image Processing System
GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches an interactive application (e.g.…
FDA · DeviceGE Medical Systems SCSWorldwide distribution - United States Nationwide and the countries of…Official notice → - US
Stryker Neurovascular recalls INZONE DETACHMENT SYSTEM, REF: M00345100950
Embolization coil detachment system devices may experience premature battery drain causing devices to: 1) Not power on; 2) Power on with faint audible and visual indicators; 3) Be unable to detach a coil as intended,…
FDA · DeviceStryker NeurovascularWorldwide - US Nationwide distribution including in the states of PA, AZ, FL,…Official notice → - US
Acumed LLC recalls Acumed Hexalob Screw various sizes: REF Numbers: : 3070-27008 2.7mm x 8mm NL Hexalobe Screw; 3070-27009 2.7mm x 9mm NL Hexalobe Screw;…
Due to manufacturing error, hexalobe screws used with wrist fixation system may break during use.
FDA · DeviceAcumed LLCUS Nationwide distribution in the states of AR, CA, CO, CT, FL, GA, IL, KS,…Official notice → - US
PFM MEDICAL INC. recalls Multi-Snare Set: 5 mm x 125 cm, REF: 147305; 10 mm x 125 cm, REF: 147310
A snare catheter including luer lock, indicated for removal or manipulation of a foreign body in the vascular system, failed to meet the biocompatibility requirements for in-vitro-cytotoxicity, which if in contact with…
- US
Ventec Life Systems, Inc. recalls VOCSN+Pro package, REF: PRT-00853-000; VOCSN+Pro unit, REF: PRT-00490-001
Respiratory system intended to provide continuous/intermittent ventilator support, may have a damaged back-up battery supporting backup alarm function, which may result in the backup alarm not activating during loss of…
FDA · DeviceVentec Life Systems, Inc.US Nationwide distribution in the state of UT.Official notice → - US
TMJ Solutions Inc recalls TMJ Bilateral Implants, REF: CHG020
Custom temporomandibular joint implant may have contained incorrect patient-specific components that led to a poor fit of the implant, leading to a right-sided open bite.