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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84451

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

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Event summary

Timeline bucket
November 21, 2019
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Stryker GmbH

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

Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures Unstable elbow dislocation Multiple extremity fractures Radial osteotomies Foot and ankle fractures Paediatric fractures

Z-0781-2020
Recall number
Z-0781-2020
Initiated
November 21, 2019
Classification
Class II
Status
Terminated
Recalling firm
Stryker GmbH
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Pin To Rod Coupling could not clamp the pin and rod as intended

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Unknown

An exact joined enrichment record exists, but none supplies supported root-cause wording. This is not an FDA finding of an unknown cause.

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Pin To Rod Coupling could not clamp the pin and rod as intended

Code information

Lot Number: D30875 UDI : (01)07613327089158(10)D30875

Distribution pattern

Worldwide distribution - US Nationwide distribution including states of FL, MA, MI, NC, NJ, TX, WA, and countries of Brazil, Italy, South Africa, Netherlands, Spain, and China.

Field note

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