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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 87971

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

Open FDA event record

Event summary

Timeline bucket
April 09, 2021
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
SPINEART SA

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

PERLA TL Lateral Connector Open - Product Usage: intended to be used with autograft and/or allograft. Pediatric pedicle screw fixation is limited to a posterior approach. Models: PERLA TL Lateral Connector Open, 15mm PERLA TL Lateral Connector Open, 30mm

Z-1975-2021
Recall number
Z-1975-2021
Initiated
April 09, 2021
Classification
Class II
Status
Terminated
Recalling firm
SPINEART SA
Quantity
44 units in the U.S.

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Due to external labelling error/mix-up. Affected product external labels list the incorrect rod size.

Code information

Reference Number/Product Description/Batch Number: -TLF-LC OP 15-S / PERLA TL Lateral Connector Open, 15mm / 5-2983 -TLF-LC OP 30-S / PERLA TL Lateral Connector Open, 30mm / 5-2993

Distribution pattern

U.S. Nationwide distribution in the states of CA, MA, and NC. O.U.S.: Not provided