Recall Z-2664-2017
Exactech, Inc. · initiated May 25, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
EXACTECH Equinoxe Glenoid Reamer - Catalog #: 321-05-38, Catalog #: 321-05-42, and Catalog #: 321-05-46
Codes / lots: All Lots
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.
FDA-determined cause: Error in labeling
Action taken
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 Kaya@exac.com. 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 kaya@exac.com or by phone at (352) 377-1140
Details
- Recall number
- Z-2664-2017
- Initiated
- May 25, 2017
- Terminated
- July 26, 2019
- Product code
- HTX – Rongeur
- Quantity
- 813
- 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
- Recalling firm
- Exactech, Inc., Gainesville, FL
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-2663-2017 Class II | EXACTECH Equinoxe Reverse Starter Reamer - Catalog #: 321-05-01Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the… | 05/25/2017Terminated |
| Z-2665-2017 Class II | EXACTECH Equinoxe Modular Reverse Pilot-Tip Starter Reamer - Catalog #: 321-25-01Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the… | 05/25/2017Terminated |
| Z-2666-2017 Class II | EXACTECH Equinoxe Modular Reverse Pilot-Tip Reamer, Catalog #: 321-25-38, Catalog #:…Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the… | 05/25/2017Terminated |
| Z-2667-2017 Class II | EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Starter Reamer Catalog #: 321-45-01Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the… | 05/25/2017Terminated |
| Z-2668-2017 Class II | EXACTECH Equinoxe Narrow Modular Reverse Pilot-Tip Reamer // Catalog #: 321-45-38…Instructions for use (IFU) is updated to clarify the proper technique and instrumentation to ream the… | 05/25/2017Terminated |