Z-2663-2017Class II

EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01

Name: Z-2663-2017 EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01
Creator: Exactech, Inc.
Published: 2017-05-25
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2017-05-25 / Terminated / root cause: labeling and UDI

FDA source

Exactech, Inc. began a recall of EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01 on 2017-05-25. FDA classified it as Class II and gives the reason as "Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may...". 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-2663-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-25
Posted: 2017-07-03
Terminated: 2019-07-26
Recalling firm: Exactech, Inc.
Product: EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01
Product code: HTX Rongeur
Reason for recall: Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the Glenoid, i.e., to include a caution statement that the surgeon should ream on-axis and that reaming off-axis may result in instrument breakage.
Root cause tag: labeling and UDI
FDA root cause: Error in labeling
Action: On May 22, 2017 Exactech sent a Notification to all their Direct Accounts an Distributors telling them that a new updated technical techniques LIT # 718-01-30 Rev J is now available in their website (www.exac.com) or can be requested by contacting the Customer Service Representative at 800-392-2832, fax 352-378-2617 or via e-mail at [email protected]. This updated the technical techniques for implantation for Equinoxe Platform Shoulder System to clarify the proper technique for use of the Pilot Tip Reamers, i.e., to include caution statement that the surgeon should avoid applying a bending force to the pilot tip reamer and should avoid using the reamer to retract the humeral head, as this may result in instrument breakage. The notification also request to forward and informed this notice to all the accounts that have received this product and to complete and return the attached Field Advisory Notice Respond Form within 5 days of receipt. For more information please contact: Kaya Davis, Inventory Representative at [email protected] or by phone at (352) 377-1140
Quantity in commerce: 382
Distribution: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, Hawaii and Puerto Rico Australia, Austria, Brazil, Canada, China, France, Germany, Greece, India, Italy, Korea, Luxembourg, Singapore, South Africa, Spain, Sweden, Switzerland, The Netherlands and United Kingdom
Product codes and lots: All Lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2663-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2663-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-07-03
Z-2664-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-07-03
Z-2665-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-07-03
Z-2666-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-07-03
Z-2667-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-07-03
Z-2668-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-07-03

Product code HTX

The FDA recall record names no cleared device, and no clearance has been matched to it.

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)