—#154803

Product

Logic Fit Tibial Tamp Head

FDA product code: LXH — Orthopedic Manual Surgical Instrument
Device class: Class 1
Medical specialty: Orthopedic
Affected lot / code info: 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.

Why it was recalled

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 (FDA determination)

Error in labeling

Action the firm took

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

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

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

Timeline

Recall initiated: 2017-05-25
Posted by FDA: 2017-06-19
Terminated: 2019-07-26
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #154803. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.