Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76442

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

Open FDA event record

Event summary

Timeline bucket
February 14, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Zimmer 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

Orthosize Templating Version 1.2.6 Echo Bi-Metric Hip Stem Digital Templates. For preoperative planning of orthopedic surgery.

Z-1495-2017
Recall number
Z-1495-2017
Initiated
February 14, 2017
Classification
Class II
Status
Terminated
Recalling firm
Zimmer Biomet, Inc.
Quantity
3232

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Digital templates were created with the incorrect files.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Software Manufacturing/Software Deployment

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Digital templates were created with the incorrect files.

Code information

Orthosize Templating Version 1.2.6

Distribution pattern

Worldwide distribution. US Nationwide including Puerto Rico, Canada, Argentina, Australia, Austria, Belgium, Chile, China, Denmark, Finland, France, Germany, Greece, India, Italy, Japan, Korea, Lithuania, Malaysia, Mexico, Netherlands, Nicaragua, Norway, Pakistan, Poland, Portugal, Romania, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, United Kingdom.