Exactech, Inc. recalls Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER…
Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
Read the official notice →- Date
- 2025-09-24
- Country
- United States
- Brand
- Exactech
- Product
- Exactech Equinoxe, Reverse Shoulder Humeral Liners, 322-38-00 (145-DEG PE 38MM HUM LINER +0), REF: 322-38-03 (145-DEG PE 38MM HUM LINER…
- Classification
- Class II
- Units
- Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Exactech recalls
- 2026-03-18
USExactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Impactor handle may be missing cross-pin
FDA · DeviceExactech, Inc.US: CA CO FL GA HI ID IL IN KS KY LA MA MD ME MN NV NY OH OK PR SC TN TX VA WI…Official notice →- 2025-11-26
- US
Exactech, Inc. recalls Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product…
Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
- 2025-02-19
- US
Exactech, Inc. recalls AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM 140-32-28 AM EHXL 0¿ LNR H…
Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
FDA · DeviceExactech, Inc.U.S.: AR, CA, CO, FL, GA, HI, IL, IN, KS, KY, LA, MD, MN, NV, NY, OH, OK,…Official notice → - 2024-07-10
- US
Exactech, Inc. recalls Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20, SZ. M; c) 100-22-21,…
The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types…
FDA · DeviceExactech, Inc.Worldwide - US distribution in Puerto Rico and the countries of Great Britain,…Official notice → - 2024-06-26
- US
Exactech, Inc. recalls OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
- 2024-04-10
- US
Exactech, Inc. recalls Exactech Equinoxe GLENOID,POSTERIOR AUGMENT, PEGGED, 12o, RIGHT, FOR CEMENTED USE ONLY, Mates with: a) 38, 41, 44, 47 head, Small, Item…
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional…
FDA · DeviceExactech, Inc.Nationwide and Australia, Austria, Belgium, Brazil, Chile, Canada , China,…Official notice →
Other drugs & medical recalls in the United States
- 2025-09-24
- US
Philips Medical Systems (Cleveland) Inc recalls Pinnacle Radiation Therapy Planning System: Multimodality Simulation Workspace 18.0.5 Model 870258 UDI code:…
Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet First Prone) orientations.
FDA · DevicePhilips Medical Systems (Cleveland) IncU.S Nationwide distribution including in the states of AL, AR, AZ, CA, CO, CT,…Official notice → - US
Medical Information Technology, Inc. recalls MEDITECH Expanse Laboratory (LAB), Microbiology (MIC), Anatomical Pathology (PTH), Genetics (GEN). Calculator/data…
Entering multiple keys that trigger input simultaneously may remove data from first field of screens and/or questionnaires with more than one field.
FDA · DeviceMedical Information Technology, Inc.Worldwide distribution - US Nationwide and the countries of British Virgin…Official notice → - US
Agilent Technologies Denmark ApS recalls Brand Name: FLEX Monoclonal Mouse Anti-Human CD20cy, Clone L26, Ready-to-Use (Dako Omnis) Model/Catalog Number: GA60461-2…
Their is the potential for weak staining which may result in false negative CD20 identification.
FDA · DeviceAgilent Technologies Denmark ApSUS Nationwide distribution including in the states of Alabama, California,…Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls VITROS Chemistry Products LAC Slides. Catalog Number: 8150112. 1 Sales Unit = contains 5 cartridges of 18 slides, for a total…
VITROS Chemistry Products LAC Slides on VITROS XT 3400 and VITROS XT 7600 Systems are experiencing an increased occurrence of calibration failure related to lots from coating 0130 and above with Condition Code TH4-63J…
- US
Boston Scientific Neuromodulation Corporation recalls Vercise Deep Brain Stimulation Systems Surgical Implant Manual, Document Number: 92328632-09
Wire break(s) have occurred in rechargeable deep brain stimulation implantable pulse generators, implanted in the submuscular pectoral location. Wire breaks prevent successful stimulation, thus requiring device…
FDA · DeviceBoston Scientific Neuromodulation CorporationWorldwide - US Nationwide distribution including in the states of MN, FL, CO,…Official notice → - US
Max Mobility LLC recalls Max Mobility/Permobil Smart Drive MX2+ SpeedControl Dial Ref: MX2-3DCMC use in conjunction with the SmartDrive MX2+ Wheelchair Power…
Due to a faulty electrical connection between the speed control Dial and the wheelchair motor, their is a potential for lost of control of the device potentially resulting in minor or major injuries.
FDA · DeviceMax Mobility LLCUS: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO…Official notice →