Exactech, Inc.: Medical Device Recall in 2012 - (Recall #: Z-2116-2012)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2012.

Data Source: FDA.

Product Description:

Equinoxe Fixed Angle Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty.

Product Classification:

Class II

Date Initiated: June 15, 2012

Date Posted: August 8, 2012

Recall Number: Z-2116-2012

Event ID: 62566

Reason for Recall:

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 affected parts as having a ten year shelf life; however, the packaging configuration that was used it qualified to a five year

Status: Terminated

Product Quantity: 54,877 units for all products in Recall Event

Code Information:

Size: 0mm Catalog Number: 300-25-00 Serial Range: 1999574-2381151

Distribution Pattern:

Worldwide Distribution - USA including FL, MO, MA, AL, KY, IN, NC, LA,PA, VA, OH, NY, ME, MI, TX, KS, TN, OK, NJ, WA, CO, GA, CA, MN, IA, OR, and IL and Internationaly to Austria, Luxenbourg, Sweden, Germany, Spain, France, Greece, Italy, Nederland, United Kingdom, Canada, India, Australia, Switzerland, and Sao Palo.

Voluntary or Mandated:

Voluntary: Firm initiated