Z-2115-2012Class II

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

Name: Z-2115-2012 Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
Creator: Exactech, Inc.
Published: 2012-06-15
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2012-06-15 / Terminated / root cause: labeling and UDI

FDA source

Exactech, Inc. began a recall of Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty on 2012-06-15. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2115-2012
Classification: Class II
Status: Terminated
Initiated: 2012-06-15
Posted: 2012-07-31
Terminated: 2013-07-03
Recalling firm: Exactech, Inc.
Product: Equinoxe Anatomic Replicator Plate Intended for Primary and Reverse Total Shoulder Arthroplasty
Product code: KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
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
Root cause tag: labeling and UDI
FDA root cause: Labeling False and Misleading
Action: 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.
Quantity in commerce: 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, Germany, Spain, France, Greece, Italy, Nederland, United Kingdom, Canada, India, Australia, Switzerland, and Sao Palo.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2115-2012
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2115-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-08-01
Z-2116-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-08-01
Z-2117-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-08-01
Z-2118-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-08-01
Z-2119-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-08-01
Z-2120-2012	Class II	Terminated	Voluntary: Firm initiated	2012-08-08	2012-08-01

Product code KWS

K042021Class IIExactech Equinoxe Shoulder SystemExactech, Inc. / cleared 2004-10-26

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)