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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73258

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

Open FDA event record

Event summary

Timeline bucket
February 16, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Biomet, 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

HipLOC CHS Plate/Lag Screw Introducer

Z-0885-2016
Recall number
Z-0885-2016
Initiated
February 16, 2016
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
23 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

A complaint was received where the Hiploc Plate/Lag Screw Introducer was undersized and would not accept the introducor coupling screw. It appears now that not all parts manufactured to Rev A drawing were reworked.

Code information

Catalog Number: 35-000263; and Lot Number Identification: 1807188, 1807189, 1943563, and 2577847.

Distribution pattern

US Distribution to the states of : MO, UT, AZ, IL, PA, KY, MI, NC, NJ, MN and GA., and Internationally to The Netherlands.