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.
Read the official notice →- Date
- 2024-06-26
- Country
- United States
- Brand
- Exactech
- Product
- OPTETRAK Inset Patella, Item Numbers: a) 200-05-23, 23MM; b) 200-05-26, 26MM; c) 200-05-29, 29MM
- Classification
- Class II
- Units
- Worldwide 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Exactech recalls
- 2025-09-24
USExactech, 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 → - 2024-04-10
- 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 → - 2023-12-27
- US
Exactech, Inc. recalls AcuMatch Hip System, Catalog Number 142-32-27
Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
FDA · DeviceExactech, Inc.US NY, TX, IN, IL, MN, KY, VA, MD, TN, GA, NH, ME, SC, NV, FL, AR and…Official notice → - 2023-07-05
- US
Exactech, Inc. recalls Exactech Ergo Impactor Handle, Catalog #321-09-05.
The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
FDA · DeviceExactech, Inc.Distribution was made to AR, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD,…Official notice →
Other drugs & medical recalls in the United States
- 2024-07-03
- US
Coast Quality Pharmacy, LLC dba Anazao Health recalls Progesterone 200 mg, Compounded, 90-count bottle, Rx, Dissolve One Sublingual Tablet After Dinner Nightly,…
Presence of Foreign Substance; Broken metal piece found embedded in tablet.
- 2024-06-26
- US
Beaver Visitec International, Inc. recalls Xstar Safety Slit Knife, 2.75 mm 45¿ Bevel Up, Model Number 378227
The wrong configuration of the blade was in the package. The bevel was on the opposite side, instead of being in front (bevel up) it was in the back (bevel down).
FDA · DeviceBeaver Visitec International, Inc.Worldwide distribution - US Nationwide and the countries of Canada, UK, and…Official notice → - US
NxStage Medical Inc recalls NxStage PureFlow-B Solution, Premixed Dialysate for Hemodialysis, Device Catalog Numbers RFP-400, RFP-401, RFP-402, RFP-403, RFP-404,…
The smaller chamber of the two chamber bag is bursting when nurses are attempting to mix the two chambers prior to use. The electrolyte fluid in the small chamber of the NxStage PureFlow B Solution has a pH of less…
- US
C.R. Bard Inc recalls Bard Medical SureStep Foley Tray System, 16 Fr., Catalog #A319416AM; and Bard Medical Bardex IC Complete Care Infection Control…
Some of the devices may function incorrectly resulting in no temperature display or erratic temperatures being displayed on the temperature monitoring devices.
FDA · DeviceC.R. Bard IncDistribution was nationwide. There was no government/military/foreign…Official notice → - US
Howmedica Osteonics Corp. recalls Gray Revision Instrument System Accessory Tray/Case, Catalog/Part Number: 6210-9-910
The design of the HRIS Storage & Sterilization Case and Tray P/N 6210-9-900 and the Gray Revision Instrument System Accessory Tray/Case P/N 6210-9-910 may lead to misuse of the Gray Revision Instruments including…
FDA · DeviceHowmedica Osteonics Corp.Worldwide distribution - US Nationwide and the countries of Argentina,…Official notice → - US
Baxter Healthcare Corporation recalls Centrella Max - The Centrella Smart+ Bed is intended for use in healthcare environments as a patient support system to prevent…
There is a potential for the top cover of the hospital bed mattress to delaminate as a result of improper cleaning and lack of adequate details on the appropriate use of cleaning agents containing bleach.
FDA · DeviceBaxter Healthcare CorporationDistribution was made nationwide. There was also government/military…Official notice →