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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 66333

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

Open FDA event record

Event summary

Timeline bucket
August 27, 2013
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

6 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 6

GENESIS(R) II, POSTERIOR STABILIZED ARTICULAR INSERT, SIZE 1-2, 13 MM QTY: (1), REF 71420806, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

Z-0444-2014
Recall number
Z-0444-2014
Initiated
August 27, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew Inc
Quantity
16 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

Code information

Batch No. 12GT20908

Distribution pattern

Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.

device · product 2 of 6

GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 13 MM QTY: (1), REF 71420820, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

Z-0445-2014
Recall number
Z-0445-2014
Initiated
August 27, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew Inc
Quantity
45 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

Code information

Batch No. 12GT20824

Distribution pattern

Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.

device · product 3 of 6

GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 3-4, 9 MM QTY: (1), REF 71421508, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

Z-0446-2014
Recall number
Z-0446-2014
Initiated
August 27, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew Inc
Quantity
80 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

Code information

Batch No. 12GT20822

Distribution pattern

Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.

device · product 4 of 6

GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 9 MM QTY: (1), REF 71421515, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

Z-0447-2014
Recall number
Z-0447-2014
Initiated
August 27, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew Inc
Quantity
32 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

Code information

Batch No. 12GT20904

Distribution pattern

Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.

device · product 5 of 6

GENESIS(R) II, PS HIGH FLEXION ARTICULAR INSERT, SIZE 5-6, 11 MM QTY: (1), REF 71421516, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

Z-0448-2014
Recall number
Z-0448-2014
Initiated
August 27, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew Inc
Quantity
46 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

Code information

Batch No. 12GT20775

Distribution pattern

Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.

device · product 6 of 6

GENESIS(R) II, MOBILE BEARING ARTICULAR INSERT RIGHT, SIZE 5, 9 MM QTY: (1), REF 71621509, STERILE EO, Smith & Nephew, Inc. Memphis, TN 38116 USA Orthopedic

Z-0449-2014
Recall number
Z-0449-2014
Initiated
August 27, 2013
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew Inc
Quantity
8 pieces

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Package design/selection

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Tyvek(TM) lid on one, or both, of the two trays that form a double barrier around the insert may not have been adequately sealed.

Code information

Batch No. 12GT20940

Distribution pattern

Worldwide Distribution - USA including Nevada and Internationally to United Arab Emirates, Italy, Spain, Belgium, Bulgaria, Poland, France, Japan, Netherlands, Australia, Turkey, Russian Federation, Germany and United Kingdom.