PlainRecalls

Exactech, Inc.

148 recalls on record · Latest: Mar 18, 2026

Exactech, Inc. Recall Insight

Exactech, Inc. appears on 148 federal recall records indexed by PlainRecalls, out of 83,949 total recalls tracked across the FDA, CPSC, NHTSA, and USDA FSIS. That represents approximately 0.176% 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 Aug 18, 2021.

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.

FDA Devices Moderate Aug 18, 2021

Exactech BIOLOX delta Femoral Head, 36m O.D., REF 170-36-00. Hip prosthesis component.

FDA Devices Moderate Jul 28, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-40-XX, Novation GXL Liner, Neutral, 40mm. O…

FDA Devices Moderate Jul 28, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-32-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL …

FDA Devices Moderate Jul 28, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-40-XX, Novation GXL Liner, Lipped Ant, 40mm;…

FDA Devices Moderate Jul 28, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-28-XX, Acumatch GXL 15 Degree, +5 Lat Liner,…

FDA Devices Moderate Jul 28, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-22-XX, Novation GXL 10 deg Liner, G00, 22mm …

FDA Devices Moderate Jul 28, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-28-XX, Acumatch GXL 15 Degree Liner, 28mm; N…

FDA Devices Moderate Jul 28, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-40-XX, Novation GXL Liner, +5mm Lateralized,…

FDA Devices Moderate Jul 28, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-32-XX, Acumatch GXL 0 Degree Liner, 32mm; an…

FDA Devices Moderate Jul 28, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 138-32-XX, Novation GXL Liner, 10 Deg Face, 32mm…

FDA Devices Moderate Jul 28, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-22-XX, Novation GXL Neutral Liner, G00, 22mm…

FDA Devices Moderate Jul 28, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-36-XX, Novation GXL Liner, +5mm Lateralized,…

FDA Devices Moderate Jul 28, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 134-28-XX, Acumatch GXL, Ext Cov Liner, 28mm. O…

FDA Devices Moderate Jul 28, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-32-XX, Novation GXL Liner, +5mm Lateralized,…

FDA Devices Moderate Jul 28, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 130-36-XX, Acumatch GXL 0 Degree Liner, 36mm; an…

FDA Devices Moderate Jul 28, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 136-28-XX, Novation GXL Liner, +5mm Lateralized,…

FDA Devices Moderate Jul 28, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 104-28-XX, MCS +5GXL Liner 5/15 DEG and MCS GXL …

FDA Devices Moderate Jul 28, 2021

Exactech Connexion GXL acetabular polyethylene liners used in the following systems: Catalog numbers 132-22-XX, Novation GXL Liner, G00, 22mm ID; and…

FDA Devices Moderate Jan 27, 2021

Equinoxe Humeral Stem, Primary, Press Fit, 11mm

FDA Devices Moderate Nov 25, 2020

Catalog 314-13-23, Equinoxe Cage Glenoid, Posterior Augment, Left, Medium

FDA Devices Moderate Nov 4, 2020

Equinoxe Platform Fracture Stem, 6.5mm, Left - Product Usage: The Equinoxe Platform Fracture Stem is indicated for cemented use only.

FDA Devices Moderate Oct 7, 2020

Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 22 mm.

FDA Devices Moderate Oct 7, 2020

Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit 4.5 x 18 mm.

FDA Devices Moderate Sep 9, 2020

The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm.

FDA Devices Moderate Mar 4, 2020

Truliant Splined Stem Extension, 18mm x 120mm - Product Usage: The devices are used in a cemented total knee prosthesis system, which provides femora…

FDA Devices Moderate Feb 5, 2020

Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 10.5mm, REF 304-22-11 - Product Usage: The Equinoxe Shoulder System is indicated …

FDA Devices Moderate Feb 5, 2020

Exactech equinoxe PLATFORM FRACTURE, HUMERAL STEM, CEMENTED, Right, 6.5mm, REF 304-22-07 - Product Usage: The Equinoxe Shoulder System is indicated f…

FDA Devices Moderate Jun 5, 2019

Opteform Allograft Disc, 30mm 3mm, 2cc, Catalog Number 600-03-30

FDA Devices Moderate Jun 5, 2019

Opteform Allograft Disc, 90mm x 5mm, 22cc, Catalog Number 600-03-90

FDA Devices Moderate Jun 5, 2019

Opteform Allograft Disc, 45mm x 5mm, 8cc, Catalog Number 600-03-45

FDA Devices Moderate Mar 6, 2019

Equinoxe Preserve Humeral Stem, 8mm Product Usage: The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degene…

FDA Devices Moderate Oct 10, 2018

Equinoxe Reverse Drill Bit Kit, Catalog Number 321-20-00 Product Usage: Shoulder surgery

FDA Devices Moderate Sep 26, 2018

Optetrak Logic CC Stem Extension, 22mm x 160mm The OPTETRAK Logic CC Total Knee System is indicated for use in skeletally mature individuals under…

FDA Devices Moderate Sep 12, 2018

Tibial Alignment Guide, REF 351-10-00 Vantage Fixed Ankle system components for ankle replacements.

FDA Devices Moderate Dec 13, 2017

Vantage Total Ankle Tibial Insert, Fixed Bearing, 10 mm, Left, Size 3. Exactech Inc. Intended for patients with ankle joints damage by severe rheu…

FDA Devices Moderate Dec 13, 2017

Vantage Total Ankle Tibial Insert, Fixed Bearing, 7 mm, Left, Size 3. Exactech Inc., Intended for patients with ankle joints damage by severe r…

FDA Devices Moderate Nov 29, 2017

Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX. .

FDA Devices Moderate Nov 29, 2017

Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .

FDA Devices Moderate Nov 29, 2017

Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX.

FDA Devices Moderate Nov 29, 2017

Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX.

FDA Devices Moderate Nov 29, 2017

Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.

FDA Devices Moderate Nov 29, 2017

Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.

FDA Devices Moderate Nov 29, 2017

Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX.

FDA Devices Moderate Nov 29, 2017

Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.

FDA Devices Moderate Nov 29, 2017

Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.

FDA Devices Moderate Nov 29, 2017

Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.

FDA Devices Moderate Nov 29, 2017

Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX.

FDA Devices Moderate Nov 29, 2017

Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.

FDA Devices Moderate Nov 29, 2017

Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX.

FDA Devices Moderate Nov 29, 2017

Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX.

Nearby Manufacturers

Other firms with recall activity tracked in the PlainRecalls index.

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Data Sources

  • Source: FDA + CPSC + NHTSA + USDA FSIS — federal recall filings naming this firm. Verify with FDA, CPSC, NHTSA, or USDA FSIS directly.
  • Source: PlainRecalls Manufacturer Index — firm-level aggregation across all four federal recall feeds