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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 83218

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

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Event summary

Timeline bucket
July 01, 2019
Product types
Device
Classifications
Class III
Statuses
Terminated
Recalling firm wording
Clariance 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

Erisma- LP posterior fixation system with the below specifically affected products: 1. Erisma-LP polyaxial screws - 4.5, 5.5, 6.5, 7.5, 8.5, 9.5, 105 mm (all lengths); 2. Erisma-LP Screwdriver; 3. Erisma-LP T20 Wrench; 4. Erisma-LPT20 Snap Fit Tightening Wrench

Z-1986-2019
Recall number
Z-1986-2019
Initiated
July 01, 2019
Classification
Class III
Status
Terminated
Recalling firm
Clariance Inc
Quantity
4,090 units distributed in the US

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the polyaxial screw to become disassembled during implant.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Use error

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Potential for the polyaxial screw to become disassembled during implant.

Code information

1. Catalog Numbers: 181545XX, 181555XX, 181565XX, 181575XX, 181585XX, 181595XX, 181510XX; 2. Catalog Number 18710024; 3. Catalog Number 18720000; 4. Catalog Number 01720001

Distribution pattern

Nationwide distribution to CA, IL, IN, NY, OH, TX.