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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63665

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

Open FDA event record

Event summary

Timeline bucket
November 07, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
DePuy Spine, 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

9 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 9

DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl Product Code: 1867-15-870 Spinal Implant Component.

Z-0705-2013
Recall number
Z-0705-2013
Initiated
November 07, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Spine, Inc.
Quantity
34 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

Code information

All lots

Distribution pattern

Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.

device · product 2 of 9

DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl Product Code: 1867-15-880 Spinal Implant Component.

Z-0706-2013
Recall number
Z-0706-2013
Initiated
November 07, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Spine, Inc.
Quantity
36 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

Code information

All lots

Distribution pattern

Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.

device · product 3 of 9

DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl Product Code: 1867-15-899 Spinal Implant Component.

Z-0707-2013
Recall number
Z-0707-2013
Initiated
November 07, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Spine, Inc.
Quantity
N/A

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

Code information

All lots

Distribution pattern

Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.

device · product 4 of 9

DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl Product Code: 1867-15-970 Spinal Implant Component.

Z-0708-2013
Recall number
Z-0708-2013
Initiated
November 07, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Spine, Inc.
Quantity
24 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

Code information

All lots

Distribution pattern

Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.

device · product 5 of 9

DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl Product Code: 1867-15-980 Spinal Implant Component.

Z-0709-2013
Recall number
Z-0709-2013
Initiated
November 07, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Spine, Inc.
Quantity
34 uits

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

Code information

All lots

Distribution pattern

Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.

device · product 6 of 9

DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl Product Code: 1867-15-999 Spinal Implant Component.

Z-0710-2013
Recall number
Z-0710-2013
Initiated
November 07, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Spine, Inc.
Quantity
23 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

Code information

All lots

Distribution pattern

Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.

device · product 7 of 9

DePuy Spine VIPER POLY SCREW 5.5 10 X 70MM Tl Product Code: 1867-15-170 Spinal Implant Component.

Z-0711-2013
Recall number
Z-0711-2013
Initiated
November 07, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Spine, Inc.
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

Code information

All lots

Distribution pattern

Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.

device · product 8 of 9

DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl Product Code: 1867-15-180 Spinal Implant Component.

Z-0712-2013
Recall number
Z-0712-2013
Initiated
November 07, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Spine, Inc.
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Polyaxial screws 8x 80 and larger may disassociate when inserting in the Ilium., VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head

Code information

All lots

Distribution pattern

Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.

device · product 9 of 9

DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl Product Code: 1867-15-199 Spinal Implant Component.

Z-0713-2013
Recall number
Z-0713-2013
Initiated
November 07, 2012
Classification
Class II
Status
Terminated
Recalling firm
DePuy Spine, Inc.
Quantity
10 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Component change control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Polyaxial screws 8x 80 and larger may disassociate when inserting in the ilium. VIPER large diameter long screws in high-torque circumstances, the screw shank has the potential to separate from the polyaxial head.

Code information

All lots

Distribution pattern

Worldwide Distribution - US (nationwide) including the states of: AZ, CA, FL, HI, IL, MD,MI, MO,NC, TN, TX and the country of Australia.