Exact FDA event identifier

Event 74271

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

Event summary

Timeline bucket: May 26, 2016
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

LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 LEFT, A/P 54.5 MM, M/L 62 MM, REF 71421373 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION Hinge Knee System is for cemented use only.

Z-2090-2016

Recall number: Z-2090-2016
Initiated: May 26, 2016
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 12 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The surface inside of the femoral component, where cement is applied for adhesion, is below specification.

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 surface inside of the femoral component, where cement is applied for adhesion, is below specification.

Code information

Lot codes: 15LM08792,15LM15638,15LM15639,15MM03011,15MM03012,15MM03014,15MM09814

Distribution pattern

Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.

device · product 2 of 6

LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 3 RIGHT, A/P 54.5 MM, M/L 62 MM, REF 71421363 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION Hinge Knee System is for cemented use only.

Z-2091-2016

Recall number: Z-2091-2016
Initiated: May 26, 2016
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The surface inside of the femoral component, where cement is applied for adhesion, is below specification.

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 surface inside of the femoral component, where cement is applied for adhesion, is below specification.

Code information

Lot Code: 15LM08798

Distribution pattern

Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.

device · product 3 of 6

LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 LEFT, A/P 58.5 MM, M/L 66 MM, REF 71421374 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION Hinge Knee System is for cemented use only.

Z-2092-2016

Recall number: Z-2092-2016
Initiated: May 26, 2016
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 33 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The surface inside of the femoral component, where cement is applied for adhesion, is below specification.

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 surface inside of the femoral component, where cement is applied for adhesion, is below specification.

Code information

Lot codes: 15KM09161,15KM09163,15KM09175,15KM17714,15KM17800,15KM17806,15KM17809,15KM17817,15LM01258,15LM01259,15LM01260,15LM01261,15LM08803,15LM08816,15LM08820,15LM08821,71421375,15KM09183

Distribution pattern

Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.

device · product 4 of 6

LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 4 RIGHT, A/P 58.5 MM, M/L 66 MM, REF 71421364 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION Hinge Knee System is for cemented use only.

Z-2093-2016

Recall number: Z-2093-2016
Initiated: May 26, 2016
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 16 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The surface inside of the femoral component, where cement is applied for adhesion, is below specification.

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 surface inside of the femoral component, where cement is applied for adhesion, is below specification.

Code information

Lot codes: 15KM20807,15KM20808,15KM20811,15KM20812,15LM08258,15LM12482,15MM03005,15MM03007

Distribution pattern

Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.

device · product 5 of 6

LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 LEFT, A/P 62 MM, M/L 70 MM, REF 71421375 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION Hinge Knee System is for cemented use only.

Z-2094-2016

Recall number: Z-2094-2016
Initiated: May 26, 2016
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The surface inside of the femoral component, where cement is applied for adhesion, is below specification.

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 surface inside of the femoral component, where cement is applied for adhesion, is below specification.

Code information

Lot codes: 15KM09184,15LM08835,15LM08837,15LM08839,15LM08840

Distribution pattern

Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.

device · product 6 of 6

LEGION(TM) HK FEMORAL ASSEMBLY, SIZE 5 RIGHT, A/P 62 MM, M/L 70 MM, REF 71421365 The LEGION Hinge Knee System is indicated for: 1. Rheumatoid arthritis. 2. Post-traumatic arthritis, osteoarthritis, or degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result. 3. Failed osteotomies, unicompartmental replacement, or total knee replacement. 4. Posterior stabilized knee systems are designed for use in patients in primary and revision surgery, 5. Constrained and hinge knee systems are designed for use in patients in primary and revision surgery. The LEGION Hinge Knee System is for cemented use only.

Z-2095-2016

Recall number: Z-2095-2016
Initiated: May 26, 2016
Classification: Class II
Status: Terminated
Recalling firm: Smith & Nephew, Inc.
Quantity: 97 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0

The surface inside of the femoral component, where cement is applied for adhesion, is below specification.

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 surface inside of the femoral component, where cement is applied for adhesion, is below specification.

Code information

Lot codes: 15JM04561,15JM04570,15JM04589,15KM08936,15KM08937,15KM08940,15KM08942,15KM08948,15KM08949,15KM09010,15KM09011,15KM09013,15KM09014,15KM09015,15KM09016,15LM09119,15LM09122,15LM09123,15LM09124,15LM12483,15LM12484,15LM12486,15LM12488,15LM15652,15MM09829,15MM09833,16AM12222,16AM12224,16AM12235,16AM12237,16AM12240,16AM12243,16AM12255,16AM12268

Distribution pattern

Worldwide Distribution and US Nationwide including Puerto Rico and the countries of Australia, Austria, Belgium, Canada, France, Germany, Italy, Netherlands, South Africa, Sweden, and UK.