Device product
Equinoxe Reverse Compression Screw Intended for Primary and Reverse Total Shoulder Arthroplasty.
Z-2117-2012
Product summary
- Firm
- Exactech, Inc.
- Event
- Event 62566
- Status
- Terminated
- Classification
- Class II
- Quantity
- 54,877 units for all products in Recall Event
- Official record key
device-enforcement:Z-2117-2012
Official wording
Reason: 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
Code information: Sizes: 4.5x18mm Catalog # 320-20-18 Serial Range 1610445-2381151 4.5x22mm Catalog # 320-20-22 Serial Range 1610391-2381151 4.5x26mm Catalog # 320-20-26 Serial Range 1611237-2381151 4.5x30mm Catalog # 320-20-30 Serial Range 1617556-2381151 4.5x34mm Catalog # 320-20-34 Serial Range 1611290-2381151 4.5x38mm Catalog # 320-20-38 Serial Range 1610260-2381151 4.5x42mm Catalog # 320-20-42 Serial Range 1630006-2381151 4.5x46mm Catalog # 320-20-46 Serial Range 1644317-2381151
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.
Derived failure modes
-
Unknown
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