RegWardenFDA facility compliance records
Facility

Exactech Sarasota

61 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2009: 1 recalls; 2011: 3 recalls; 2012: 3 recalls; 2013: 3 recalls; 2014: 3 recalls; 2015: 4 recalls; 2016: 4 recalls; 2017: 10 recalls; 2018: 4 recalls; 2019: 6 recalls; 2020: 6 recalls; 2021: 4 recalls; 2022: 1 recalls; 2023: 2 recalls; 2024: 4 recalls; 2025: 2 recalls, 1 inspections, 1 warning letters; 2026: 1 recalls1’09’103’113’123’133’144’154’1610’174’186’196’204’211’222’234’244’251’26
  • Recalls (61)
  • Inspections (1)
  • Warning letters (1)

Devices registered here (1)

  • Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
    Product code JWH (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3560

Recalls & enforcement

20261 record
20252 records
  • Class IIOngoing2025-09-05
    Due to products that have not completed design updates and performance testing being released/distributed. Products may not conform to design and performance criteria.
  • Class IIOngoing2025-08-15
    Reverse Shoulder humeral liners have an articular surface position outside of the dimensional specification within the labeling.
20244 records
  • Class IIOngoing2024-12-31
    Due to the lack of the Ethylene Vinyl Alcohol (EVOH) barrier layer.
  • Class IIOngoing2024-04-26
    The AcuMatch L-Series 22mm Inner Diameter Bipolar Hip Liner lots were packaged without the specified ethylene vinyl alcohol (EVOH) layer. Between 2004 and August 2021, our packaging process utilized two different types of packaging materials: 1) Low Density Polyethylene (LDPE), N…
  • Class IIOngoing2024-04-18
    Exactech is recalling all affected UHMWPE (ultra-high molecular weight polyethylene) knee patella components packaged in out of specification vacuum bags.
  • Class IIOngoing2024-03-06
    The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
20232 records
  • Class IIOngoing2023-11-21
    Exactech has received 3 complaints for 4 devices related to a loss of vacuum in the inner-most vacuum bag.
  • Class IIOngoing2023-06-05
    The ball and spring housed within the locking mechanism of the handle can dislodge during disassembly or during impaction.
20221 record
  • Class IIOngoing2022-08-11
    Specific GXL acetabular polyethylene liners, packaged in non-conforming bags, may adversely impact the device and contribute to accelerated wear.
20214 records
  • Class IIOngoing2021-08-30
    Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
  • Class IIOngoing2021-06-29
    Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.
  • Class IICompleted2021-06-29
    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).
  • Class IICompleted2021-05-11
    The HAT trial contains a retaining ring that has shown the potential to disengage during use.
20206 records
  • Class IIOngoing2020-11-09
    Potential for incorrect Instructions For Use (IFU) included with an Equinoxe Humeral Stem, Primary, Press Fit, 11mm package.
  • Class IITerminated2020-10-06
    The product may be mislabeled.
  • Class IITerminated2020-09-25
    The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
  • Class IITerminated2020-08-24
    Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
  • Class IIOngoing2020-08-10
    The Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm, were found to have a labeling error. Exactech is recalling the Vantage Total Ankle Tibial Insert, Fixed Bearing, Size 4, Right 10mm because they were found to have a labeling error. The upper right corner…
  • Class IIOngoing2020-01-27
    These Truliant Splined Stem Extension, 18mm x 120mm were found to have a labeling error. The upper right corner of the label incorrectly identifies the implant size as 17mm x 80mm when the implant size is 18mm x 120mm.
20196 records
  • Class IITerminated2019-12-03
    Labels with incorrect translations were identified by Exactech is a distributor in the Netherlands. The translations on the outer labels include the word " long" in all languages other than the original English version. The implants are standard length fracture stems.
  • Class IITerminated2019-10-02
    Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
  • Class IITerminated2019-09-10
    Potential for the wire to fracture at the threads and remain in the glenoid.
  • Class IITerminated2019-07-24
    The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
  • Class IITerminated2019-04-26
    The Opteform Disc-30mm, Opteform Disc-45mm, and Opteform Disc-90mm were potentially exposed to higher temperatures than those documented in the IFU due to a failure of the cold storage equipment.
  • Class IITerminated2019-03-13
    2.5 Truliant Fit Trays were mismarked as 3
20184 records
  • Class IITerminated2018-12-05
    Possibility that the Equinoxe Preserve Humeral Stem, 8mm, was inadvertently packaged with an Optetrak Knee System instructions for use (IFU) rather than the Equinoxe Preserve Humeral Stem IFU as intended .
  • Class IIOngoing2018-08-21
    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 intended.
  • Class IITerminated2018-07-13
    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 10885862525629, when it should read 10885862525628.
  • Class IIOngoing2018-05-08
    Potentially have non-conforming internal threads.
201710 records
  • Class IITerminated2017-10-09
    Wrong device description of the label identifying the implant
  • Class IITerminated2017-09-19
    There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.
  • Class IITerminated2017-08-31
    Potentially mislabeled.
  • Class IITerminated2017-07-11
    Vix Bit may fracture during use.
  • Class IITerminated2017-06-23
    The Truliant Tibial Trial Handle's pin may disassociate from the main body.
  • Class IITerminated2017-05-25
    Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
  • Class IITerminated2017-05-25
    The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to remove the tamp assembly from the bone, i.e., to include a caution statement about the potential for instrument breakage if the tamp handle/guide is…
  • Class IITerminated2017-05-22
    The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to the bone, i.e., to include a caution statement about the potential for instrument breakage if bending or torsional forces…
  • Class IITerminated2017-05-16
    Possible inner labeling and packaged device not matching the outer label on the box.
  • Class IITerminated2017-04-07
    Missing Screw in carton. Nine (9) serial numbers were identified as being inadvertently packaged as one per carton when two per carton are required.
20164 records
20154 records
  • Class IITerminated2015-09-28
    Incorrect external and internal packaging labels. Exactech has identified nineteen (19) Acapella One Interbody Fusion Device Lordotic (05-090-01-1610) were packaged as Acapella One Interbody Fusion Device Parallel (05-090-02-1610)
  • Class IITerminated2015-09-23
    Eight (8) pieces did not receive the specified Hydroxyapatite (HA) coating.
  • Class IITerminated2015-05-21
    Shipped to a single consignee prior to completion of final inspection.
  • Class IITerminated2015-02-13
    Incorrectly packaged. Outer and inner labeling may incorrectly identify the size of the enclosed device.
20143 records
20133 records
  • Class IITerminated2013-09-11
    Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard.
  • Class IITerminated2013-05-30
    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 the instrument.
  • Class IITerminated2013-02-01
    A dimensional mismatch was identified which can potentially allow for interference between devices.
20123 records
  • Class IITerminated2012-11-05
    Recall of Novation Crown Cup Connection GXL Neutral Liners Catalog No. (130-32-53) and Novation Crown Cup Connection GXL + 5mm Lateralized Liners Catalog No. (136-32-53). Exactech discovered the device labeling was inadvertently transposed.
  • Class IITerminated2012-06-15
    Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Intervertebral fusion devices due to the firm determining that the device labeling identifies the affecte…
  • Class IITerminated2012-01-24
    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 in a non-sterile condition.
20113 records
  • Class IITerminated2011-10-17
    Exactech, Inc. of Gainesville, FL recalled their Optetrak Proximal Tibial Spacer after the devices were determined to be dimensionally incompatible to mate as intended with the Logic Tibial Tray.
  • Class IITerminated2011-09-23
    Exactech, Inc. Gainesville, FL is recalling their Optetrak Cemented Trapezoid Tibial Tray, Size 1F/1T, 2F/1T and the Optetrak Rotating Bearing Knee Tibial Tray, Finned, Cemented Tibial Tray, Size 2F/1T. Both trays have the potential to be mislabeled.
  • Class IITerminated2011-08-19
    Exactech, Inc. of Gainesville, FL is recalling their Optetrak Logic Posterior Stabilized Tibial Insert, Size 6 after the device was determined to be out of dimensional specification.
20091 record

FDA inspections (1)

  • OAI2025-07-25
    Official Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “Exactech Sarasota (FEI 3008658204) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3008658204-exactech-sarasota/

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