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.
Read the official notice →- Date
- 2023-07-05
- Country
- United States
- Brand
- Exactech
- Product
- Exactech Ergo Impactor Handle, Catalog #321-09-05.
- Classification
- Class II
- Units
- Distribution was made to AR, CA, CO, FL, GA, HI, ID, IL, IN, KS, KY, LA, MD,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2024-07-10
USExactech, 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 → - 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 → - 2022-09-21
- US
Exactech, Inc. recalls GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. ACUMATCH GXL 0 DEGREE LINER 28MM SZ E, REF 130-28-25 b.…
Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
FDA · DeviceExactech, Inc.Worldwide distribution: US (nationwide) and OUS (foreign) countries of:…Official notice → - 2021-10-13
- US
Exactech, Inc. recalls OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b.…
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
FDA · DeviceExactech, Inc.Worldwide distribution - US Nationwide distribution and the countries of…Official notice →
Other drugs & medical recalls in the United States
- 2023-07-12
- US
Strides Pharma Inc. recalls Losartan Potassium Tablets, USP, 25 mg, 1000 film coated tablets per bottle, Rx Only, Manufactured by: Vivimed Life Sciences Private…
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
- US
- US
Amerisource Health Services LLC recalls Tizanidine Tablets, USP, 4 mg, 100 Tablets (10 tablets x 10 unit dose blister packs) per carton, Rx Only, Packaged and…
Failed Dissolution Specifications: this repackaged product was recalled by the manufacturer, Dr. Reddy's Laboratories, Inc., due to out of specification results for dissolution.
- 2023-07-05
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls LINK Endo-Model Modular Knee Prosthesis System Femoral Segment, Size 3, Left
The firm discovered through customer complaints that device segments may not meet specifications.
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Domestic: AL, GA, IL, IN, KS, NJ, NY, and TX. Foreign: Argentina, Australia,…Official notice → - US
SEDECAL SA recalls wDR 2.2 Mobile Digital Diagnostic X-Ray System
There is a software login in issue that may prevent the user from logging in.
FDA · DeviceSEDECAL SADistribution throughout United States including Puerto Rico and US Virgin…Official notice → - US
Appliedvr recalls RelieVR REF: RVX-2002, Rx Only. Virtual reality behavioral therapy device for pain relief.
There is the potential for the program software to malfunction which will not allow it to move forward to the next session.