Recall archive
59 recalls · page 3 of 3
Reported Jul 30, 2014
NOVATION Femoral Stem, Tapered Extended offset, plasma- coated, press fit. Catalog number 160-01-13 intended to be…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — The femoral stem is lacking specified plasma coating.
FDA (openFDA device enforcement)
Reported Mar 26, 2014
Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium…
FDA (openFDA device enforcement)
Reported Feb 12, 2014
***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Product · Product details · Reason for recall — Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard.
FDA (openFDA device enforcement)
Reported Aug 7, 2013
Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Product · Product details — When torque is applied to the Articulated Driver at the maximum angle, the cross pin may shift out of position, potentially leading to disassembly of…
FDA (openFDA device enforcement)
Reported Mar 27, 2013
Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog #…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand — A dimensional mismatch was identified which can potentially allow for interference between devices.
FDA (openFDA device enforcement)
Reported Feb 13, 2013
Exactech NOVATION CROWN CUP, NEUTRAL LINER, Use with Crown Cup Only, GXL UHMWPE, SN 0123456, REF 130-32-53. Exactech…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Product · Product details · Reason for recall — Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners…
1 more product in this recall
FDA (openFDA device enforcement)
Reported Sep 19, 2012
REF 101-05-20***NOVATION MODULAR DRILL BIT LENGTH: 20mm, DIAMETER 3.2mm***Use with 20mm Screw***STERILE***EXACTECH 2320…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Product · Product details · Reason for recall — Exactech Inc. of Gainesville, FL is recalling their Novation Modular Drill Bits after the devices were reported to have been used by end user while…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Sep 12, 2012
OPTETRAK LOGIC TIBIAL INSERT POSTERIOR STABILIZED***Match Component Colors 6 YELLOW, 11mm, Use with LOGIC Femoral and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Reason for recall — Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert, Size 6 after the device was determined to be…
FDA (openFDA device enforcement)
Reported Aug 29, 2012
OPTETRAK LOGIC Proximal Tibial Spacer & Screws (2) 2.5 LT BLUE Size 2.5, 8mm***STERILE***Match insert/spacer/tray…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Reason for recall — Exactech, Inc. of Gainesville, FL recalled their Optetrak Proximal Tibial Spacer after the devices were determined to be dimensionally incompatible…
FDA (openFDA device enforcement)
Reported Aug 8, 2012
Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Reason for recall — Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter…
5 more products in this recall
FDA (openFDA device enforcement)
Reported Aug 1, 2012
Product is labeled in part: "***OPTETRAK***TIBIAL TRAY***TRAPEZOID CEMENTED***Ti Alloy*** SIZE 1F/1T, 2F/1T***FOR…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.Exactech, Inc.
Matched: Brand · Product details · Reason for recall — Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1F/1T, 2F/1T and the Optetrak Rotating Bearing Knee…
1 more product in this recall
FDA (openFDA device enforcement)
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