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.
Read the official notice →- Date
- 2021-10-13
- Country
- United States
- Brand
- Exactech
- Product
- OPTETRAK LOGIC Polyethylene Tibial Inserts, labeled as the following: a. OPTETRAK Logic PS Tibial Inserts, Product Line 02-012-35-XXXX; b.…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide distribution and the countries of…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 → - 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 → - 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 →
Other drugs & medical recalls in the United States
- 2021-10-13
- US
Contamac Solutions, Inc. recalls Nutrifill Scleral, Hybrid, and Gas Permeable (GP) Lens Insertion Solution, Physiologic Formula, Preservative Free, 35 Single-use 10ml…
Contact lens solution may contain foreign material
FDA · DeviceContamac Solutions, Inc.US Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO, CT, DC,…Official notice → - US
Aesthetics Systems Usa Inc recalls Action De Gala, FuSion Conductive Gel - Product Usage: Intended for use in acoustic coupling of ultrasound transducer to tissue.
Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue:…
FDA · DeviceAesthetics Systems Usa IncU.S. Nationwide distribution in the states of WA, TX, AK, AZ, CA.Official notice → - US
Johnson & Johnson Surgical Vision Inc recalls TECNIS Eyhance IOLs are permanent intraocular implants intended for implantation in the capsular bag. The TECNIS…
Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit.…
FDA · DeviceJohnson & Johnson Surgical Vision IncU.S. Nationwide distribution in the state of IL.Official notice → - US
Paltop Advanced Dental Solutions Ltd recalls Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical…
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified.…
FDA · DevicePaltop Advanced Dental Solutions LtdUS Nationwide distribution. No foreign distribution from US.Official notice → - US
GE Healthcare, LLC recalls Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
A software anomaly exists in the Centricity Universal Viewer study management feature in which study changes are not propagated to either the Centricity Enterprise Archive (EA) or another Vendor Neutral Archive (VNA).
FDA · DeviceGE Healthcare, LLCAR, IL, ME, MS, NE, NJ, NY, and TN Belgium, Canada, Costa Rica, France,…Official notice → - US
Welch Allyn Inc Mortara recalls ELI, Burdick and McKesson brand 280 Resting Electrocardiographs (ELI 280, MLBUR280 and BUR280), Model Numbers: ELI280-DDB-ADAAX,…
The devices malfunction under specific operator workflows.
FDA · DeviceWelch Allyn Inc MortaraDistribution was nationwide, including Puerto Rico. Foreign distribution was…Official notice →