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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84706

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

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Event summary

Timeline bucket
January 09, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Implant Direct Sybron Manufacturing LLC

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

SwishPlus Implant 5.7mmD x 8mmL, SBM 6.5mmD Platform, Part Number 925708

Z-1126-2020
Recall number
Z-1126-2020
Initiated
January 09, 2019
Classification
Class II
Status
Terminated
Quantity
11 units

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
label and cap labels were incorrect

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 a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.

Code information

Lot # 109038 No affected devices distributed within the US.

Distribution pattern

US: None OUS: Iceland, Sweden, Spain,