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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 71985

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

Open FDA event record

Event summary

Timeline bucket
June 03, 2015
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

3 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 3

Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING FEMORAL HEAD, STERILE R, Rx only, REF Numbers: 74121138 (38 MM), 74123140 (40 MM), 74121142 (42 MM), 74123144 (44 MM), 74121146 (46 MM). Product Usage: Hip joint prosthesis

Z-2745-2015
Recall number
Z-2745-2015
Initiated
June 03, 2015
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
5,987 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.

Code information

all codes

Distribution pattern

Worldwide Distribution - US Nationwide and countries of: Australia, Austria, Bahrain (UAE), Belgium, Canada, China, Denmark, Finland, Germany, Hong Kong, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand and United Arab Emirates (UAE).

device · product 2 of 3

Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING ACETABULAR CUP W/IMPACTOR, REF Numbers: 74120144 (44 MM), 74120146 (46 MM), 74122146 (46 MM), 74122148 (48 MM), 74120148 (48 MM), 74120150 (50 MM), 74122150 (50 MM), 74122152 (52 MM), 74120152 (52 MM), 74120154 (54 MM) Product Usage: Hip joint prosthesis

Z-2746-2015
Recall number
Z-2746-2015
Initiated
June 03, 2015
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
10,167 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.

Code information

all codes

Distribution pattern

Worldwide Distribution - US Nationwide and countries of: Australia, Austria, Bahrain (UAE), Belgium, Canada, China, Denmark, Finland, Germany, Hong Kong, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand and United Arab Emirates (UAE).

device · product 3 of 3

Smith & Nephew BIRMINGHAM HIP (TM) RESURFACING DYSPLASIA CUP W/IMPACTOR, REF Numbers: 74120246 (46 MM), 74122248 (48 MM), 74120250 (50 MM), 74122252 (52 MM), 74120254 (54 MM) Product Usage: Hip joint prosthesis

Z-2747-2015
Recall number
Z-2747-2015
Initiated
June 03, 2015
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
624 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.

Code information

all codes

Distribution pattern

Worldwide Distribution - US Nationwide and countries of: Australia, Austria, Bahrain (UAE), Belgium, Canada, China, Denmark, Finland, Germany, Hong Kong, Italy, Japan, Malaysia, Mexico, Netherlands, New Zealand, Norway, Poland, Portugal, Saudi Arabia, Singapore, South Africa, Spain, Sweden, Switzerland, Thailand and United Arab Emirates (UAE).