Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84545

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

Open FDA event record

Event summary

Timeline bucket
December 11, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Brasseler USA I Lp

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

Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.

Z-0884-2020
Recall number
Z-0884-2020
Initiated
December 11, 2019
Classification
Class II
Status
Terminated
Recalling firm
Brasseler USA I Lp
Quantity
56 packs of 6

App-derived interpretation

Labeling or packaging reason.labeling_packaging · v1.0.0
incorrect product labels

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling mix-ups

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tubes were incorrectly labeled as KM169-39-76 Single Diamond Threaded Steinmann Pins.

Code information

Lot Number NR8ZR

Distribution pattern

US: AZ, AR, FL

Field note

Send feedback

We'll only use this to respond to your feedback.