Z-2662-2017Class II

Logic Fit Tibial Tamp Head

Name: Z-2662-2017 Logic Fit Tibial Tamp Head
Creator: Exactech, Inc.
Published: 2017-05-25
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2017-05-25 / Terminated / root cause: labeling and UDI

FDA source

Exactech, Inc. began a recall of Logic Fit Tibial Tamp Head on 2017-05-25. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2662-2017
Classification: Class II
Status: Terminated
Initiated: 2017-05-25
Posted: 2017-06-19
Terminated: 2019-07-26
Recalling firm: Exactech, Inc.
Product: Logic Fit Tibial Tamp Head
Product code: LXH Orthopedic Manual Surgical Instrument
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2662-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2662-2017	Class II	Terminated	Voluntary: Firm initiated	2017-07-12	2017-07-03

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)