Exactech, Inc.
211 recalls on record · Latest: Mar 18, 2026
Exactech, Inc. Recall Insight
Exactech, Inc. appears on 211 federal recall records indexed by PlainRecalls, out of 101,704 total recalls tracked across the FDA, CPSC, and NHTSA. That represents approximately 0.207% of the federal archive, a data point that is only interpretable alongside production volume, product mix, and decades of operation, because a high recall count alone does not establish fault. Large, diversified firms that sell tens of millions of units across many categories will mechanically accumulate more recall records than small manufacturers, even when their defect rates per unit shipped are comparable or lower. The most recent action on this firm is dated Mar 18, 2026, which is the anchor point for assessing whether enforcement is currently active or historical.
On this page of 50 entries, severity tagging shows 0 critical, 50 moderate, and 0 lower-severity recalls. Affected-unit counts are disclosed on 50 of 50 entries, unit-count disclosure is more common on CPSC and NHTSA actions and less common on FDA drug/device recalls, where lot numbers and distribution scope substitute for absolute totals. The records on this page span 1 distinct product categories, with issuing agencies dominated by FDA Devices (50). The date window on this page runs from Nov 29, 2017 to Nov 4, 2020.
Manufacturer-level browsing is useful when monitoring a single firm for patterns, whether recalls cluster around one product family (suggesting a specific design or supplier issue) or scatter across the firm's entire catalog (which can indicate systemic quality-control problems or deliberate regulator attention). Clicking into each recall reveals the specific hazard, remedy, and distribution scope that together determine whether a consumer is actually at risk. For decisions that depend on being current, deciding whether a product in your home is safe, whether to return a gift, or whether to accept a replacement, always verify the recall number on the issuing agency's site, because federal agencies amend, terminate, and re-scope recalls over time and only the agency's live record reflects the current legal status. This page aggregates what agencies have published publicly and is intended for consumer awareness and research.
Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Equinoxe Platform Fracture Stem, 6.5mm, Right - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.
Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.
The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.
Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femora…
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System is indicated …
Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated f…
2.4mm x 2.5 Fluted Pin Pouch; Catalog Number: 351-90-22; Orthopedic surgical instrument used in the implantation of the Vantage Total Ankle System -…
Ergo 3.2mm K-wire - Product Usage: The devices is used assist the surgeon in the implantation of Equinoxe Shoulder System components according to a c…
Threaded Offset Cup Impactor - Product Usage: To assist the surgeon in the implantation of Novation hip system components according to a conventional…
Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30
Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90
Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45
Truliant Tibial Fit Tray Cemented SZ 3F / 3T, Catalog Number 02-022-45-3030 Product Usage: Knee joint patellofemorotibial polymer/metal/polymer s…
Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degene…
Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery
Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals under…
Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.
Exactech GPS Total Shoulder Application 3.2mm Vix Bit Orthopedic surgical tool
Alteon HA Femoral Stem, Press-Fit, Extended Offset, Cementless, HA Coated, Collared, Size 5 All Exactech Hip Systems are indicated for use in sk…
Equinoxe Cage, Glenoid, Alpha, Small Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degen…
Equinoxe Cage, Glenoid, Alpha, Medium Product Usage: The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with dege…
Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheu…
Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe r…
Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX. .
Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .
Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX.
Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX.
Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.
Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.
Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX.
Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.
Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.
Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.
Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX.
Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.
Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX.
Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX.
Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX.
Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.
Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.
Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.
Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX.
Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX.
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX.
Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX.
Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.
Optetrak Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, Sterile, RX.
Nearby Manufacturers
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Data Sources
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. Recalls are aggregated across FDA, CPSC and NHTSA filings that name this firm; the total reflects the federal record, not an independent investigation. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.