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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 84180

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

Open FDA event record

Event summary

Timeline bucket
November 08, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Wright Medical Technology, 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

12 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 12

SWANSON GREAT TOE, TITANIUM SZ 4, Part Number 4833104

Z-0562-2020
Recall number
Z-0562-2020
Initiated
November 08, 2016
Classification
Class II
Status
Terminated
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm discovered a lack of adequate documentation confirming sterility on certain products.

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 firm discovered a lack of adequate documentation confirming sterility on certain products.

Code information

Lot Number 1558414

Distribution pattern

US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain

device · product 2 of 12

ORTHOLOC 3DI PLT SYS STERILE, LOCKING SCREW, 3.5 x 38mm Sterile, Part Number 58S03538

Z-0563-2020
Recall number
Z-0563-2020
Initiated
November 08, 2016
Classification
Class II
Status
Terminated
Quantity
40 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm discovered a lack of adequate documentation confirming sterility on certain products.

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 firm discovered a lack of adequate documentation confirming sterility on certain products.

Code information

Lot Number 1568030

Distribution pattern

US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain

device · product 3 of 12

PRO-STIM 10cc INJECTABLE, Part Number 86SR0410

Z-0564-2020
Recall number
Z-0564-2020
Initiated
November 08, 2016
Classification
Class II
Status
Terminated
Quantity
19 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm discovered a lack of adequate documentation confirming sterility on certain products.

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 firm discovered a lack of adequate documentation confirming sterility on certain products.

Code information

Lot Number 1564697

Distribution pattern

US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain

device · product 4 of 12

INBONE STEM, TIBIAL, TOP, Part Number 200011901

Z-0565-2020
Recall number
Z-0565-2020
Initiated
November 08, 2016
Classification
Class II
Status
Terminated
Quantity
65 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm discovered a lack of adequate documentation confirming sterility on certain products.

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 firm discovered a lack of adequate documentation confirming sterility on certain products.

Code information

Lot Number 1540433

Distribution pattern

US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain

device · product 5 of 12

VALOR SCREW 5.0MM X 45MM LEN, Part Number 4151150045

Z-0566-2020
Recall number
Z-0566-2020
Initiated
November 08, 2016
Classification
Class II
Status
Terminated
Quantity
54 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm discovered a lack of adequate documentation confirming sterility on certain products.

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 firm discovered a lack of adequate documentation confirming sterility on certain products.

Code information

Lot Number 1547961

Distribution pattern

US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain

device · product 6 of 12

Dart Fire HEADED SCREW 4.0X 32MM, Part Number D1S40032S

Z-0567-2020
Recall number
Z-0567-2020
Initiated
November 08, 2016
Classification
Class II
Status
Terminated
Quantity
77 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm discovered a lack of adequate documentation confirming sterility on certain products.

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 firm discovered a lack of adequate documentation confirming sterility on certain products.

Code information

Lot Number 1555125

Distribution pattern

US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain

device · product 7 of 12

Darco STERILE HEADED DRILL BIT 4.4MM , Part Number 777S06514

Z-0568-2020
Recall number
Z-0568-2020
Initiated
November 08, 2016
Classification
Class II
Status
Terminated
Quantity
66 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm discovered a lack of adequate documentation confirming sterility on certain products.

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 firm discovered a lack of adequate documentation confirming sterility on certain products.

Code information

Lot Number 1555781

Distribution pattern

US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain

device · product 8 of 12

EVANS OPENING WEDGE PLATE 10MM, Part Number 58S30010

Z-0569-2020
Recall number
Z-0569-2020
Initiated
November 08, 2016
Classification
Class II
Status
Terminated
Quantity
30 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm discovered a lack of adequate documentation confirming sterility on certain products.

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 firm discovered a lack of adequate documentation confirming sterility on certain products.

Code information

Lot Number 1556150

Distribution pattern

US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain

device · product 9 of 12

SWANSON FINGER JOINT #1, Part Number 4700001

Z-0570-2020
Recall number
Z-0570-2020
Initiated
November 08, 2016
Classification
Class II
Status
Terminated
Quantity
20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm discovered a lack of adequate documentation confirming sterility on certain products.

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 firm discovered a lack of adequate documentation confirming sterility on certain products.

Code information

Lot Number 1555726

Distribution pattern

US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain

device · product 10 of 12

SWANSON FINGER JOINT #2, Part Number 4700002

Z-0571-2020
Recall number
Z-0571-2020
Initiated
November 08, 2016
Classification
Class II
Status
Terminated
Quantity
18 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm discovered a lack of adequate documentation confirming sterility on certain products.

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 firm discovered a lack of adequate documentation confirming sterility on certain products.

Code information

Lot Number 1574468

Distribution pattern

US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain

device · product 11 of 12

SWANSON TRAPEZIUM IMPLANT, Part Number 4520002

Z-0572-2020
Recall number
Z-0572-2020
Initiated
November 08, 2016
Classification
Class II
Status
Terminated
Quantity
20 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm discovered a lack of adequate documentation confirming sterility on certain products.

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 firm discovered a lack of adequate documentation confirming sterility on certain products.

Code information

Lot Number 1536734

Distribution pattern

US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain

device · product 12 of 12

CPS CALCANEAL PLATE SML 54MM, Part Number DCS2805001

Z-0573-2020
Recall number
Z-0573-2020
Initiated
November 08, 2016
Classification
Class II
Status
Terminated
Quantity
42 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The firm discovered a lack of adequate documentation confirming sterility on certain products.

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 firm discovered a lack of adequate documentation confirming sterility on certain products.

Code information

Lot Number 1552873

Distribution pattern

US and Norway, Italy, Germany, France, South Africa, UK, Taiwan, Austria, Japan, Turkey, Denmark, Canada, Switzerland, Belgium, The Netherlands, Spain