Skip to content
Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 64247

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

Open FDA event record

Event summary

Timeline bucket
November 28, 2012
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
The Anspach Effort, 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

45 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 45

ANSPACH***Knotless Suture Anchor Deployment Tool, Custom***Rx Only*** This device is intended to be used with Anspach Systems

Z-1875-2014
Recall number
Z-1875-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
4

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the Anspach Custom Devices. The units and the records of these products were not consistent with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling the Anspach Custom Devices. The units and the records of these products were not consistent with Quality System requirements.

Code information

Part Numbers: 98-0006, 98-0009. Serial Numbers: 20030001, 20030002 20033501, 20033502.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 2 of 45

ANSPACH***REF 98-0020***Modified Arthroscopic Knotless Suture Anchor Deployment Tool with Suture Puller***Rx Only*** This device is intended to be used with Anspach Systems

Z-1876-2014
Recall number
Z-1876-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number 98-0020, Serial Number: 200423

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 3 of 45

ANSPACH***REF 98-0022***8 mm Coarse Headless Screw with Driver***Rx Only*** This device is intended to be used with Anspach Systems

Z-1877-2014
Recall number
Z-1877-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number 98-0022. Serial Number: 2000040

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 4 of 45

ANSPACH***REF 98-0029***8 mm Coarse Threaded Headless Bone Screw***Rx Only*** This device is intended to be used with Anspach Systems

Z-1878-2014
Recall number
Z-1878-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
10

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number 98-0029; Serial Number: 20000263

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 5 of 45

ANSPACH***Custom MCA5-1SD with Extended Exposure***Rx Only*** This device is intended to be used with Anspach Systems

Z-1879-2014
Recall number
Z-1879-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
20

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Numbers: 98-0049, 98-0051; Serial Numbers: 2000729, 2000761

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 6 of 45

ANSPACH***REF 98-0001***eMax Hand Control***Rx Only*** This device is intended to be used with Anspach Systems

Z-1880-2014
Recall number
Z-1880-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0001; Serial Numbers: 20028601, 20028602

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 7 of 45

ANSPACH***eMax2 Lower Profile Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems

Z-1881-2014
Recall number
Z-1881-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
21

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Numbers: 98-0002, 98-0004, 98-0007, 98-0030, 98-0036; Serial Numbers: 200245, 20032601, 20032602 20032603, 20032604, 20032504, 20032508, 20032502, 20032503, 20032506, 20032702, 20032701, 20032507, 20032501, 20032505, 200027203, 200027201, 200027202, 200064104.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 8 of 45

ANSPACH***REF 98-0003***Sagittal microSaw Attachment Custom***Rx Only*** This device is intended to be used with Anspach Systems

Z-1882-2014
Recall number
Z-1882-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number 98-0003; Serial Numbers: 20030101, 20030102.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 9 of 45

ANSPACH***MA Attachment, Straight version Custom***Rx Only*** This device is intended to be used with Anspach Systems

Z-1883-2014
Recall number
Z-1883-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
6

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Numbers: 98-0005, 98-0011; Serial Numbers: 200390, 200379, 20030001, 20030002, 20035201, 20035202.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 10 of 45

ANSPACH***REF 98-0008***7cm Medium Attachment Custom***Rx Only*** This device is intended to be used with Anspach Systems

Z-1884-2014
Recall number
Z-1884-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0008; Serial Numbers: 20033001, 20033002.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 11 of 45

ANSPACH***REF 98-0010***2.37mm Spiral Drill, for Short Attachment (Non-Sterile)***Rx Only*** This device is intended to be used with Anspach Systems

Z-1885-2014
Recall number
Z-1885-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
10

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0010; Serial Number: 200341

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 12 of 45

ANSPACH***Modified QD11 Attachment with Soft Tissue Protector***Rx Only*** This device is intended to be used with Anspach Systems

Z-1886-2014
Recall number
Z-1886-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
6

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Numbers: 98-0013, 98-0014; 98-0018. Serial Numbers: 20039501, 20039502, 20039601, 20039602, 20039701, 20039702.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 13 of 45

ANSPACH***REF 98-0016***eMax 2 Modified Hand Control***Rx Only*** This device is intended to be used with Anspach Systems

Z-1887-2014
Recall number
Z-1887-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
6

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0016; Serial Numbers: 200008201, 200008202, 200008203, 200008204, 200008205, 200008206.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 14 of 45

ANSPACH***REF 98-0019***Modified MDA Tube with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems

Z-1888-2014
Recall number
Z-1888-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0019; Serial Number: 200422

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 15 of 45

ANSPACH***REF 98-0021***eMax2 Console with Irrigation***Rx Only*** This device is intended to be used with Anspach Systems

Z-1889-2014
Recall number
Z-1889-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0021; Serial Numbers: A46200000001, 20042601

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 16 of 45

ANSPACH***REF 98-0023***Custom 5 cm Extension Bearing Sleeve***Rx Only*** This device is intended to be used with Anspach Systems

Z-1890-2014
Recall number
Z-1890-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0023; Serial Number: 2000288

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 17 of 45

ANSPACH***REF 98-0024***Nose Cone Cover***Rx Only*** This device is intended to be used with Anspach Systems

Z-1891-2014
Recall number
Z-1891-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
12

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0024; Serial Number: 2000100

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 18 of 45

ANSPACH***REF 98-0025***Custom MDA Tube for use with MA-D20 Attachment***Rx Only*** This device is intended to be used with Anspach Systems

Z-1892-2014
Recall number
Z-1892-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0025; Serial Number: 2000220

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 19 of 45

ANSPACH***REF 98-0031***Custom Medium Attachment, with 5 mm Extended Tapered Tip***Rx Only*** This device is intended to be used with Anspach Systems

Z-1893-2014
Recall number
Z-1893-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
4

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0031; Serial Numbers: 200056702, 200030002, 200056701, 200030001.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 20 of 45

ANSPACH***REF 98-0034***Custom XMax Motor, Pneumatic with Hand Control and Custom Autolube III IRR Foot Pedal***Rx Only*** This device is intended to be used with Anspach Systems

Z-1894-2014
Recall number
Z-1894-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
16

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0034; Serial Numbers: C25302189205, C26302224202, C25302189204, C25302067902, C26302224204, C27302202503, C28302328702, C25302189204, C25302127005, C25302067902, C26302224202, C25302141301, C25302189201, C28302328705, C25302127003, C25302141304.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 21 of 45

ANSPACH***REF 98-0035***Custom eMax 2 Plus Motor with microMax Disconnect Sleeve***Rx Only*** This device is intended to be used with Anspach Systems

Z-1895-2014
Recall number
Z-1895-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
9

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0035; Serial Numbers: B51301262004, B51301262001, 2000487.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 22 of 45

ANSPACH***REF 98-0037***Custom Device SC2102 with fast stop firmware***Rx Only*** This device is intended to be used with Anspach Systems

Z-1896-2014
Recall number
Z-1896-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0037; Serial Number: 2000940.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 23 of 45

ANSPACH***Custom XMax Motor, Pneumatic***Rx Only*** This device is intended to be used with Anspach Systems

Z-1897-2014
Recall number
Z-1897-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
45

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0039, 98-0040, 98-0050, 98-0057; Serial Numbers: C06301529106, 200058302, 200058301, 200057701, 200057702, 200058402, 200058401, 200057802, 200057801, C05301514406, C06301529102, C8301529004, C08301529002, C06301529102, C08301529007, C08301529006, C08301529002, 200058301. 200069302, 200069301, D31200076202, D31200076203, D31200076204, D31200076201, D31200079014, D31200079007, D31200079015, D31200079012, D31200079010, D31200079016, D31200079001, D31200079004, D31200079008, D31200079003, D31200079009, D31200079002, D31200079006, D31200079011, D31200079017, D31200079013.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 24 of 45

ANSPACH***REF 98-0042***XMax Motor with Custom Hose***Rx Only*** This device is intended to be used with Anspach Systems

Z-1898-2014
Recall number
Z-1898-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0042; Serial Numbers: 20069801. 20069802.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 25 of 45

ANSPACH***REF 98-0043***Custom Device eMax 2 Plus Hand Control that will work with a Speed Reducer***Rx Only*** This device is intended to be used with Anspach Systems

Z-1899-2014
Recall number
Z-1899-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0043; Serial Numbers: D41200080101, D41200080102.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 26 of 45

ANSPACH***REF 98-0044***Custom Device Speed Reducer with Bumper***Rx Only*** This device is intended to be used with Anspach Systems

Z-1900-2014
Recall number
Z-1900-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
2

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0044; Serial Number: E16200088601.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 27 of 45

ANSPACH***REF 98-0048***Custom Circular ePLUS-FP***Rx Only*** This device is intended to be used with Anspach Systems

Z-1901-2014
Recall number
Z-1901-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0048; Serial Number: 200073101.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 28 of 45

ANSPACH***Custom QD11 Attachment with thinner nose tube***Rx Only*** This device is intended to be used with Anspach Systems

Z-1902-2014
Recall number
Z-1902-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
3

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0054, 98-0055; Serial Numbers: 2000782, 2000783, D51200085101.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 29 of 45

ANSPACH***REF-98-0056***Custom Device Autolube III modified with a swivel***Rx Only*** This device is intended to be used with Anspach Systems

Z-1903-2014
Recall number
Z-1903-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0056; Serial Number: 30978704

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 30 of 45

ANSPACH***REF-98-0062***Custom Device eMax2 Plus Hand Control***Rx Only*** This device is intended to be used with Anspach Systems

Z-1904-2014
Recall number
Z-1904-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0062; Serial Number: E15200088401.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 31 of 45

ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty Attachment***Rx Only*** This device is intended to be used with Anspach Systems

Z-1905-2014
Recall number
Z-1905-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
5

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: SP-3012-00; Serial Number: 200294

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 32 of 45

ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be used with Anspach Systems

Z-1906-2014
Recall number
Z-1906-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
113

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: SP-3013-00; SP-3013-01; SP-3013-02; SP-3013-03. Serial Numbers: 200042, 200044, 200014, 200056, 200064, 200055, 200044, 200038, 200013, 310009, 310007, 20043, 200145, 200144.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 33 of 45

ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with Anspach Systems

Z-1907-2014
Recall number
Z-1907-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
130

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: SP-3014-00; Serial Numbers: 200141, 200118, 200119, 200121, 200122, 200058, 200048, 200142, 200057, 200047, 200077, 200049, 200120.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 34 of 45

ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only*** This device is intended to be used with Anspach Systems

Z-1908-2014
Recall number
Z-1908-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
50

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: SP-3100-00; Serial Numbers: 200276, 200277, 200156, 200275, 310008.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 35 of 45

ANSPACH***REF SP-3101-00***Adjustable 25 Cm Mia Attachment, Custom***Rx Only*** This device is intended to be used with Anspach Systems

Z-1909-2014
Recall number
Z-1909-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: SP-3101-00; Serial Number: 200045

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 36 of 45

ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems

Z-1910-2014
Recall number
Z-1910-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
10

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: SP-4601-00; Serial Number: 200093

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 37 of 45

ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems

Z-1911-2014
Recall number
Z-1911-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
20

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: SP-4602-00; Serial Numbers: 200278, 200094

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 38 of 45

ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems

Z-1912-2014
Recall number
Z-1912-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
40

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: SP-4603-00; Serial Numbers: 200280, 200281, 200279, 200095.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 39 of 45

ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to be used with Anspach Systems

Z-1913-2014
Recall number
Z-1913-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
19

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: SP-4604-00; Serial Numbers: 200282, 200299, 200096.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 40 of 45

ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Threader***Rx Only*** This device is intended to be used with Anspach Systems

Z-1914-2014
Recall number
Z-1914-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
68

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: SP-4605-00; Serial Numbers: 200199, 200166, 200160, 200158, 200134, 200132, 200133, 200103.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 41 of 45

ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems

Z-1915-2014
Recall number
Z-1915-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
100

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: SP-4606-00; SP-5002-00. Serial Numbers: 200251, 200243, 200223, 200218, 200215, 200200, 200190, 200252, 200244, 200222.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 42 of 45

ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems

Z-1916-2014
Recall number
Z-1916-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
30

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: SP-5000-00; Serial Numbers: 200174, 200173, 200161.

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 43 of 45

ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) - Custom***Rx Only*** This device is intended to be used with Anspach Systems

Z-1917-2014
Recall number
Z-1917-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: SP-5001-00; Serial Number: 200252

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 44 of 45

ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This device is intended to be used with Anspach Systems

Z-1918-2014
Recall number
Z-1918-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0012; Serial Number: 201421

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .

device · product 45 of 45

ANSPACH***REF 98-0033***Custom Autolube Food Guard***Rx Only*** This device is intended to be used with Anspach Systems

Z-1919-2014
Recall number
Z-1919-2014
Initiated
November 28, 2012
Classification
Class II
Status
Terminated
Recalling firm
The Anspach Effort, Inc.
Quantity
1

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Anspach Effort, Inc. in Palm Beach Gardens, FL is recalling their Anspach Custom Devices. The units were not manufactured consistently with Quality System requirements.

Code information

Part Number: 98-0033; Serial Number: 200055701

Distribution pattern

Worldwide Distribution - USA including AL, CA, FL, IA, IL, KY, MN, MS, NC, OH, OK, PA, TN, TX.and Internationally to Canada, Japan, Hungary, Korea and Sweden. .