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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73069

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

Open FDA event record

Event summary

Timeline bucket
January 08, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Orthofix, 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

Firebird Spinal Fixation System Torque Limiting Handle (PN 52-1512) Intended for posterior, non-cervical pedicle, and non-pedicle fixation (T1-S2/llium).

Z-0797-2016
Recall number
Z-0797-2016
Initiated
January 08, 2016
Classification
Class II
Status
Terminated
Recalling firm
Orthofix, Inc
Quantity
36 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a possibility that the device may deliver a torque value less than the required setting after initial sterilization. In worst case, the unexpected drop in torque value may lead to the spinal construct loosening and requiring corrective surgical intervention.

Code information

BS535418105, BS535419118, BS535420030, BS535419124, BS562325021, BS535418158, BS535418038, BS535418138, BS535418012, BS535419006, BS535420039, BS535418127, BS549024010, BS535419141, BS535418081, BS535418111, BS535418117, BS535420041, BS535418144, BS535420081, BS535419151, BS562325006, BS546825008, BS535418002, BS535418013, BS535418131, BS535420006, BS535420010, BS535420026, BS535420047, BS556219012, BS556219026, BS535418109, BS535420082, BS557717009, and BS562325023.

Distribution pattern

Worldwide Distribution -- US, Spain, Italy, and Australia.