Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 62918

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

Open FDA event record

Event summary

Timeline bucket
April 25, 2011
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Extremity Medical LLC

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

IO FiX X-Post Reamer, Extremity Medical, www.extremitymedical.com; Customer Service: 888.499.0079 The X-Post Reamer is an accessory to the IO FiX Screw and Washer System that is used for reaming bone most common to orthopedic surgical procedures.

Z-0438-2013
Recall number
Z-0438-2013
Initiated
April 25, 2011
Classification
Class II
Status
Terminated
Recalling firm
Extremity Medical LLC
Quantity
156 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Employee error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Product Event Reports revealed a broken reamer experienced intra-operatively. Pre-drilling was not performed prior to reaming.

Code information

Product coding is listed as Catalog Number: Lot Number and are as follows: 118-0005:126564; 118-30016:127375; 118-30018:AP6A08; 118-30020:AP6A07.

Distribution pattern

Worldwide Distribution - USA including FL, MA, NC, CA, MD, VA, IN, AL, NJ, AZ, OK, MT, NY, OH, IA, MI, TX, WI, GA, IL, TN and NE. Internationally to Switzerland.