Home / Recalls / Exactech, Inc. / Z-2644-2017

Z-2644-2017 Class II Terminated

Recalled by Exactech, Inc. — Gainesville, FL

FDA device recall Z-2644-2017 was initiated by Exactech, Inc. on May 22, 2017 and is designated Class II. Reason for recall: The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to the bone, i.e., to include a caution stat… The recall status is terminated (terminated July 26, 2019). Affected quantity: 477.

Recall Details

Product Type
Devices
Report Date
July 5, 2017
Initiation Date
May 22, 2017
Termination Date
July 26, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
477

Product Description

Exactech 1.5" Novation Calcar Planer Guide Tip To assist the surgeon in the implantation of Novation hip system components according to a conventional technique for total hip replacement. Specifically, these instruments are reusable, surgically invasive, and intended for transient use. ech 1.5" Novation Calcar Planer Guide Tip

Reason for Recall

The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to perform calcar planing to the bone, i.e., to include a caution statement about the potential for instrument breakage if bending or torsional forces are applied.

Distribution Pattern

Worldwide Distribution - USA (nationwide) Distribution including Puerto Rico and to the states of : AL, AZ, CA, CO, FL, GA, HI, IA, ID, IL, IN, KS, LA, MA, MD, ME, MN, NC, NJ, NV, NY, OH, OK, OR, RI, SC, TN, TX, VA, WA, WI, Hawaii., and to the countries of : Argentina, Australia, Austria, Brazil, China, Colombia, France, Germany, Guatemala, India, Italy, Japan, Spain, Switzerland, Turkey, and United Kingdom

Code Information

Catalog #: 161-30-00 with the manufacturing lots #'s 38878-001, 38878-002, 49777-001, 51825-005, 51825-006, 52224-007, 51825-006, 52224-005, 52224-006, 57167-001, 59775-003, 62580-004, 66464-003, 66464-004, 70720-001, 71530-001, 73477-002, 75153-001, and 74999-001.

Other recalls by Exactech, Inc.

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  • Z-1166-2025 Class II — Novation XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 (December 31, 2024)
  • Z-1167-2025 Class II — Alteon XLE Item Number / Product Description: 140-22-70 NV EHXL NTL LNR G00 (December 31, 2024)
  • Z-1165-2025 Class II — AcuMatch XLE Item Number / Product Description: 140-28-27 AM EHXL 0¿ LNR G 28M (December 31, 2024)

FDA data resources