Skip to content

Equinoxe Anatomic Replicator Plate recallZ-2115-2012 · Exactech, Inc. · initiated Jun 15, 2012

Class II Terminated All recalls posted in July 2012

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Labeling False and Misleading

What the company is doing

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.

Recall details

Recall number
Z-2115-2012
Recall class
Class II
Status
Terminated
Initiated by the company
Jun 15, 2012
Posted by the FDA
Jul 31, 2012
Recalling firm
Exactech, Inc.
Quantity
54,877 units for all products in Recall Event
Product code
KWS
FDA submissions
K042021
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, Germany, Spain, France, Greece, Italy, Nederland, United Kingdom, Canada, India, Australia, Switzerland, and Sao Palo.

Product description

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

Code information (models, lots, serial numbers)

Sizes:  1.5 mm: Catalog Number 300-10-15 Serial Range 1653131-2381151  4.5 mm: Catalog Number 300-10-45 Serial Range 1622046-2381151

Other devices under the same FDA submission

72 devices cleared under K042021 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 62566).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page