Recall archive
59 recalls · page 1 of 3
Reported Mar 18, 2026
Brand Name: Equinoxe Ergo Product Name: Ergo Modular Impactor Handle Model/Catalog Number: 321-09-05
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — Impactor handle may be missing cross-pin
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 26, 2025
Brand Name: Equinoxe Ergo Product Name: Adjustable Angle rTSA Reamer, 42mm Model/Catalog Number: 321-59-42 Software…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and…
2 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 24, 2025
Exactech Equinoxe, Reverse Shoulder Humeral Liners, REF: 320-38-00,145-DEG PE 38MM HUM LINER +0/ 320-38-03,145-DEG PE…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Product · Product details — Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Feb 19, 2025
AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28MM 140-32-27 AM EHXL 0¿ LNR G 32MM…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Product details — Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 10, 2024
Acumatch L-Series BIPOLAR LINER, 22mm (BIPOLAR ENDOPROSTHESIS-Hip), Item Numbers: a) 100-22-19, SZ. L; b) 100-22-20,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between…
FDA (openFDA device enforcement)
Reported Jun 26, 2024
OPTETRAK Three Peg Patella, Item Numbers: a) 200-02-26, 26MM; b) 200-02-29, 29MM; c) 200-02-32, 32MM; d) 200-02-35,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Reason for recall — Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum…
3 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 10, 2024
Exactech Equinoxe GLENOID,KEELED, CEMENTED, Mates with 38, 41, 44 head, alpha curvature, Sizes: a), Small, Item Number…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Product · Product details — The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification.…
23 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 27, 2023
AcuMatch Hip System, Catalog Number 142-32-27
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Reason for recall — Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
11 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 5, 2023
Exactech Shoulder GPS Impactor Handle, Catalog #531-07-05.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Product · Product details — The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 21, 2022
GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. 0 DEG ACUMATCH CONSTRAINED LINER SZ E…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
9 more products in this recall
FDA (openFDA device enforcement)
Reported Oct 13, 2021
OPTETRAK Comprehensive Knee System, labeled as the following: a. OPTETRAK All-polyethylene CR Tibial Components, with…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Product details — Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
8 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 18, 2021
Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Product · Product details — Biolox Delta Femoral Head was packaged and labeled as 170-36-00 (36mm +0), but the device was marked as 170-36-03 (36mm +3.5).
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jul 28, 2021
Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Product · Product details — Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical…
21 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 7, 2021
Humeral Augmented Tray (HAT) trials that are components of KIT-321HAT. Each tray contains 1 of each of the following…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — The HAT trial contains a retaining ring that has shown the potential to disengage during use.
FDA (openFDA device enforcement)
Reported Jan 27, 2021
Equinoxe Humeral Stem, Primary, Press Fit, 11mm
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
FDA (openFDA device enforcement)
Reported Nov 25, 2020
Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — The product may be mislabeled.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 4, 2020
Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Oct 7, 2020
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Reason for recall — Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 9, 2020
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Reason for recall — The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage…
FDA (openFDA device enforcement)
Reported Mar 4, 2020
Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies…
FDA (openFDA device enforcement)
Reported Feb 5, 2020
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Product · Product details · Reason for recall — Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 20, 2019
2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
FDA (openFDA device enforcement)
Reported Oct 30, 2019
Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — Potential for the wire to fracture at the threads and remain in the glenoid.
FDA (openFDA device enforcement)
Reported Sep 18, 2019
Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
FDA (openFDA device enforcement)
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