Recall archive
59 recalls · page 2 of 3
Reported Jun 5, 2019
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU…
2 more products in this recall
FDA (openFDA device enforcement)
Reported May 1, 2019
Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — 2.5 Truliant Fit Trays were mismarked as 3
FDA (openFDA device enforcement)
Reported Mar 6, 2019
Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather…
FDA (openFDA device enforcement)
Reported Oct 10, 2018
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — The Equinoxe Reverse Drill Bit Kits may contain two 2mm diameter drill bits instead of one 2mm diameter drill bit and one 3.2mm diameter drill bit as…
FDA (openFDA device enforcement)
Reported Sep 26, 2018
Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — Potentially have non-conforming internal threads.
FDA (openFDA device enforcement)
Reported Sep 12, 2018
Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Reason for recall — Exactech is recalling the Tibial Alignment Guide because the Global Trade Item Number (GTIN) on the device is incorrect. The GTIN on the device reads…
FDA (openFDA device enforcement)
Reported Feb 21, 2018
Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Product · Product details — Vix Bit may fracture during use.
FDA (openFDA device enforcement)
Reported Feb 14, 2018
Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Product · Product details — Wrong device description of the label identifying the implant
FDA (openFDA device enforcement)
Reported Feb 7, 2018
Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — Potentially mislabeled.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Dec 13, 2017
Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Product · Product details — Possible inner labeling and packaged device not matching the outer label on the box.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Nov 29, 2017
Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in…
33 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 23, 2017
Truliant Tibial Trial Handle. To assist the surgeon in the implantation of Truliant Knee system components according to…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — The Truliant Tibial Trial Handle's pin may disassociate from the main body.
FDA (openFDA device enforcement)
Reported Jul 19, 2017
Exactech Optetrak Logic CC 15mm Tibial Augment Screws
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Product · Product details — Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.
FDA (openFDA device enforcement)
Reported Jul 12, 2017
Logic Fit Tibial Tamp Head
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to remove the tamp…
6 more products in this recall
FDA (openFDA device enforcement)
Reported Jul 5, 2017
Exactech 1.5" Novation Calcar Planer Guide Tip 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 · Product · Product details — The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar…
FDA (openFDA device enforcement)
Reported Jan 25, 2017
Novation Cemented Plus Femoral Stem, 12/14, Collared, Standard Offset, Matte, Cemented, Size 15.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — Products were labeled with incorrect Global Trade Item Numbers. The GTIN on the label identifies the devices as another.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Dec 28, 2016
Equinoxe Reverse Shoulder Fixed Angle Torque Defining Screw Kit
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — Disengaged screw head could potentially not be retained in the Torque Defining Screwdriver.
FDA (openFDA device enforcement)
Reported Jul 13, 2016
Novation Press-Fit Splined RDD, Extended Offset, HA Coated, 12/14 Taper Femoral Stems, Size 17. Product Usage Femoral…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — Labeled with the incorrect Global Trade Item Number (GTIN). The GTIN on the label identifies the devices as another.
1 more product in this recall
FDA (openFDA device enforcement)
Reported Jun 8, 2016
Novation Ceramic AHS Cluster-Hole Shell, Plasma Coated, 54mm, O.D. (Acetabular Cup), Catalog Number 140-01-54; For use…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — Devices were inadvertently sent to packaging and finished goods prior to the PMA site-change supplement approval.
5 more products in this recall
FDA (openFDA device enforcement)
Reported Feb 24, 2016
Exactech Acapella One Interbody Fusion Device Parallel. Orthopedic Spinal Surgery Device. Product Usage: The Acapella…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Product · Product details · Reason for recall — Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella One Interbody Fusion Device Lordotic…
FDA (openFDA device enforcement)
Reported Nov 11, 2015
Novation Element Press-Fit, Cementless, HA Coated, Collared, Standard Offset, Size 9, Femoral Hip Implant Stems,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
FDA (openFDA device enforcement)
Reported Jul 22, 2015
Altiva / Exactech Spine, Large Set Screw, Catalog Number 28202, Lot Number AS05107. Intended to provide immobilization…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Product · Product details — Incorrect thread form on the screw.
2 more products in this recall
FDA (openFDA device enforcement)
Reported Apr 29, 2015
Equinoxe 44mm Short Humeral Head Catalog Number 310-01-44. Orthopedic shoulder implant component.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.
FDA (openFDA device enforcement)
Reported Jan 14, 2015
Optetrak Asymmetric Hi-Flex Posterior Stabilized Cemented Femorals, size 3, Catalog #244-02-03, Catalog #244-03-03.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — Mislabeled
FDA (openFDA device enforcement)
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