Exact FDA event identifier

Event 77413

2 recalled-product records grouped only because every row carries this exact official event ID.

Event summary

Timeline bucket: May 30, 2017
Product types: Device
Classifications: Class II
Statuses: Terminated
Recalling firm wording: Smith & Nephew, 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

2 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 2

LEGION(R) FEM CONE IMPACTOR HEADS: a) REF 71441976, ID 18MM b) REF 71441977, ID 20MM c) REF 71441978, ID 22MM

Z-2624-2017

Recall number: Z-2624-2017
Initiated: May 30, 2017
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 36 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The incorrect Loctite adhesive was used to assemble the impactor heads.

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

The incorrect Loctite adhesive was used to assemble the impactor heads.

Code information

Lot numbers: a) 16HGA0031 b) 16HGA0034 c) 16HGA0035

Distribution pattern

US distribution to TN

device · product 2 of 2

LEGION(R) TIB CONE IMPACTOR HEADS: a) REF 71441972, ID 24MM b) REF 71441971, ID 22MM c) REF 71441973, ID 26MM d) REF 71441974, ID 28MM e) REF 71441975, ID 30MM

Z-2625-2017

Recall number: Z-2625-2017
Initiated: May 30, 2017
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 46 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The incorrect Loctite adhesive was used to assemble the impactor heads.

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

The incorrect Loctite adhesive was used to assemble the impactor heads.

Code information

Lot numbers: a) 16HGA0040 b) 16JGA0003 c) 16JGA0005 d) 16JGA0006 e) 16JGA0007

Distribution pattern

US distribution to TN