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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 76824

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

Open FDA event record

Event summary

Timeline bucket
March 15, 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

14 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 14

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 5.5MM Product Number: 72204037 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Z-1838-2017
Recall number
Z-1838-2017
Initiated
March 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

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

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Code information

Batch Numbers: G11243 G11244 G18810 G18813 G32171 G32172

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE

device · product 2 of 14

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6MM Product Number: 72204038 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Z-1839-2017
Recall number
Z-1839-2017
Initiated
March 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

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

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Code information

Batch Numbers: G10766, G10782, G18814, G18815, G32178, G32179

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE

device · product 3 of 14

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 6.5MM Product Number: 72204039 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Z-1840-2017
Recall number
Z-1840-2017
Initiated
March 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

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

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Code information

Batch Numbers: G10785, G10787, G18816, G18817

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE

device · product 4 of 14

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7MM Product Number: 72204040 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Z-1841-2017
Recall number
Z-1841-2017
Initiated
March 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

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

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Code information

Batch Numbers: F93290, F93297, G10709, G10712, G15944, G15945, G27849

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE

device · product 5 of 14

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 7.5MM Product Number: 72204041 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Z-1842-2017
Recall number
Z-1842-2017
Initiated
March 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

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

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Code information

Batch Numbers: F93305, F93306, G11233, G11234, G27843, G27847

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE

device · product 6 of 14

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8MM Product Number: 72204042 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Z-1843-2017
Recall number
Z-1843-2017
Initiated
March 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

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

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Code information

Batch Numbers: F92143, F92147, G10380, G10382, G11216, G11217 G11231, G11232, G15940, G15943, G18835, G18836, G30219 G30220, G30254, G30255, G32180, G32182, G32183, G32184

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE

device · product 7 of 14

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 8.5MM Product Number: 72204043 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Z-1844-2017
Recall number
Z-1844-2017
Initiated
March 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

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

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Code information

Batch Numbers: F93301, F93303, G04665, G27840, G27841

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE

device · product 8 of 14

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9MM Product Number: 72204044 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Z-1845-2017
Recall number
Z-1845-2017
Initiated
March 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

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

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Code information

Batch Numbers: F86213 ,F86216 , G04654, G04655, G04656, G10376 G10377, G11224, G11226, G11237, G11238, G15935, G15936, G15937, G18822, G18823, G18824, G18826, G18837, G18838, G18840, G18841, G30215, G30216, G30247, G30248, G30256, G32169, G32173, G32174 G32175, G32176, G32177

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE

device · product 9 of 14

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 9.5MM Product Number: 72204045 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Z-1846-2017
Recall number
Z-1846-2017
Initiated
March 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

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

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Code information

Batch Numbers: F93298, F93299, F93300,G11240 ,G11242, G30252, G30253

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE

device · product 10 of 14

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10MM Product Number: 72204046 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Z-1847-2017
Recall number
Z-1847-2017
Initiated
March 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

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

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Code information

Batch Numbers: F91770, F92141, G10378, G10379, G10788, G10790 G11229, G11230, G11235, G11236, G15938, G15939, G18830, G18832 G27835, G27835, G27836, G30217, G30218, G30250, G30251, G32170

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE

device · product 11 of 14

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 10.5MM Product Number: 72204047 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Z-1848-2017
Recall number
Z-1848-2017
Initiated
March 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

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

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Code information

Batch Numbers: G10802 ,G10804, G18818

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE

device · product 12 of 14

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11MM Product Number: 72204048 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Z-1849-2017
Recall number
Z-1849-2017
Initiated
March 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

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

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Code information

Batch Numbers: G15888, G15934, G18833

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE

device · product 13 of 14

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 11.5MM Product Number: 72204049 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Z-1850-2017
Recall number
Z-1850-2017
Initiated
March 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

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

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Code information

Batch Numbers: G11227,G18820

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE

device · product 14 of 14

Smith & Nephew ACUFEX TRUNAV Retrograde Drill 12MM Product Number: 72204050 The ACUFEX TRUNAV Retrograde Drill is intended for use in creating a back bore socket in bone

Z-1851-2017
Recall number
Z-1851-2017
Initiated
March 15, 2017
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

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

Potential for the cutting blade to detach from the device and/or the distal drill head to fracture during retrograde reaming

Code information

Batch Numbers: G11228, G18821

Distribution pattern

Worldwide Distribution - US (Nationwide) and Internationally to AU, CL, DB, DE, ES, FR, GB, NL, SE