Z-2662-2017 Class II Terminated
FDA device recall Z-2662-2017 was initiated by Exactech, Inc. on May 25, 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 remove the tamp assembly from the bone, i.e., to include a caution s… The recall status is terminated (terminated July 26, 2019). Affected quantity: 573.
Recall Details
- Product Type
- Devices
- Report Date
- July 12, 2017
- Initiation Date
- May 25, 2017
- Termination Date
- July 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 573
Product Description
Logic Fit Tibial Tamp Head
Reason for Recall
The firm determined that the labeling (surgical technique) should be updated to clarify the proper technique and instrumentation to remove the tamp assembly from the bone, i.e., to include a caution statement about the potential for instrument breakage if the tamp handle/guide is misused by impacting in retro-grade.
Distribution Pattern
AL, AZ, CA, CA, CO, FL, GA, 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 Puerto Rico Australia, France, Germany, India, Italy, Japan, Korea, Luxembourg, Singapore, Spain, Switzerland, The Netherlands and United Kingdom
Code Information
Catalog #: 213-75-01 Lot #'s: 37166-002, 44944-004, 44944-005, 44944-006, 48073-010, 48073-011, 48073-012, 49036-017, 51180-004, 51180-005, 51180-006, 51180-008, 51754-031, 51754-032, 51754-033, 51754-034, 59743-001, 61872-001,and 61872-002.