Recall Z-2662-2017 ยท LXH Orthopedic Manual Surgical Instrument
Exactech, Inc.
Logic Fit Tibial Tamp Head
| Date | Jun 19, 2017 (initiated May 25, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Error in labeling |
| Action | Consignees were sent a Field Advisory Notice dated 5/22/2017 by mail informing them updated surgical techniques are available on Exactech's website (www.exac.com). The notice requested consignees: Extend the information to accounts in possession of the product Complete & return the attached Field Advisory Notice Response Form to Exactech |
| Quantity | 573 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.