Overview of recall records associated with Exactech, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 113.
The device may be incorrectly laser marked as a right stem, when it should have been laser marked as a left stem.
Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
Exactech is recalling the Equinoxe Reverse Shoulder Compression Screw/Locking Cap Kit, because it may contain a incorrect length screw.
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,…
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…
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…
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…
Potential for the 2.4mm x 2.5 Fluted Pin Pouch to contain a single pin rather than four (4) as intended.
Potential for the wire to fracture at the threads and remain in the glenoid.
The threaded mechanism of the Threaded Offset Cup Impactor may be gritty and difficult to turn potentially due to entrapped blast media.
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…
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…
2.5 Truliant Fit Trays were mismarked as 3
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…
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.
Potentially have non-conforming internal threads.
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…
This page summarizes recall records in which the official source identifies Exactech, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
