Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty

FDA device recall Z-2115-2012 · posted 2012-07-31 · Terminated

Recall details

Recalling firm

Exactech, Inc.

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

Action taken

Exatech sent an Important Voluntary Recall Notice dated June 18, 2012, to all affected customers. The Notice identified the affected product, the problem, and the action to be taken by the customer. Customers were instructed to immeidately case distribution or use of the affected product. Verify that they have the affected product. Contact their Exatech Inventory Representative for further instruction on how to return their products. The firm sent out recall notification to consignees. Customers were asked to complete and return the Voluntary Recall Fax Notice to 1-352-378-2617. Customers with questions should call 1-800-392-2832. For questions regarding this recall call 352-377-1140.

Root cause

Labeling False and Misleading

Status

Terminated

Product code

KWS

Quantity affected

54,877 units for all products in Recall Event

Distribution

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,

Date initiated

2012-06-15

Date posted

2012-07-31

Date terminated

2013-07-03

Location

Gainesville, FL

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