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.
Read the official notice →- Date
- 2025-11-26
- Country
- United States
- Brand
- Exactech
- Product
- Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 46mm Model/Catalog Number: 321-59-46 Software Version: N/A Product…
- Classification
- Class II
- Units
- U.S.: SC O.U.S.: N/A
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 →- 2025-09-24
- US
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.
FDA · DeviceExactech, Inc.Worldwide - US Nationwide distribution in the states of CA, CO, FL, GA, HI,…Official notice → - 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
- 2025-11-26
- US
Berkeley Advanced Biomaterials, LLC recalls Tribio Implant 7.5mm x 40mm REF M80 SB008 UDI code: (01) 00816125023653(10) EBL10B13C(17) 270630 Tribio" Implant is…
Due to incorrect product label (Incorrect product name identified on outer packaging).
FDA · DeviceBerkeley Advanced Biomaterials, LLCU.S. Nationwide distribution in the state of TN.Official notice → - US
Medtronic Perfusion Systems recalls Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.
FDA · DeviceMedtronic Perfusion SystemsUS Nationwide distribution in the states of Hawaii and New York.Official notice → - US
POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC recalls OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed to monitor…
A labeling error was identified on the affected product. The expiration date on the kit box label and on the vial labels incorrectly stated the expiration date as 2026-01-16. The correct expiration date should be…
FDA · DevicePOLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLCUSA: AK AL,AR,AZ, CA,CO,CT,DC,DE,FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA,…Official notice → - US
Quest International, Inc. recalls Brand Name: ReQuest Measles IgG Product Name: Rubeola IgG Enzyme Linked Immunoabsorbant Assay Model/Catalog Number: 01-190 Software…
Due to distributing the measles IgG IVD without a premarket approved/cleared.
FDA · DeviceQuest International, Inc.All products were distributed in the United States. (Utah, Washington).Official notice → - US
Merit Medical Systems, Inc. recalls PhD Hemostasis Valve, REF: IN4802/K, IN4802/T, IN4918/A, IN7802/C, IN8802/C, IN9802, IN9802/A, K05-02166B, K05T-02138A, K12T-10798A,…
Hemostasis valve has a manufacturing defect and when used the valve cap may remain depressed, leading to potential leakage, which may result in procedure inconvenience and/or hemorrhage.
FDA · DeviceMerit Medical Systems, Inc.US: PA, AZ, LA, CO, FL, NC, SC, OH, AK, IL, IA, MN, TX, WI, AR, NY, CA, KS,…Official notice → - US
Medline Industries, LP recalls MEDLINE convenience kits labeled as: 1) ACH PLASTICS BREAST-LF, REF CDS983639K; 2) BREAST ABD, REF CDS984267J; 3) PLASTIC PACK, REF…
Medline Industries, LP is issuing a recall for specific item(s) and lot(s) of Medline Kits containing SafeAir Smoke Evacuation Pencils. Stryker Instruments has expanded the scope of their recall of SafeAir Smoke…