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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 77001

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
May 25, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Exactech, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

Logic Fit Tibial Tamp Head

Z-2662-2017
Recall number
Z-2662-2017
Initiated
May 25, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
573

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
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.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Error in labeling

Compare all device evidence states

Inspect official wording and provenance

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.

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.

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