FDA (Devices) recall action 63624

The Anspach Effort, Inc. recalled 21 products on 2014-01-22

The FDA (Devices) publishes a recall like this one as 21 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 21 pages.

Products: 21
Announced: 2014-01-22
Critical: 0
Units: 85,119

Why these products were recalled

The Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decide

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

1–21 of 21

ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions were unclear.
Product
MCA5-08SD - 0.8MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device validation.
Product
MCA5-1SD - 1MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions were unclear.
Product
MCA7-08SD - 0.8MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.
Product
MCA7-1SB - 1MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.
Product
MCA7-2SD - 2MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.
Product
MCA7-05SD - 0.5MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.
Product
MCA5-06SD - 0.6MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because their indications for use were broader than validated and directions were unclear.
Product
MCA5-2SD - 2MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Issues
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because their indications for use were broader than validated and directions were unclear.
Product
MCA7-06SD - 0.6MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation and directions for use were unclear.
Product
MCA7-15SD - 1.5MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions were unclear.
Product
MCA7-15SB - 1.5MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.
Product
MCA5-15SB - 1.5MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions for use were unclear.
Product
MCA7-07SD - 0.7MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions were unclear.
Product
MCA7-1SD - 1MM Diamond Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because their indications for use were broader than validated and directions were unclear.
Product
MCA5-05SD - 0.5 MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.
Product
MCA5-2SB - 2MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because the indications for use were broader than the device's validation.
Product
MCA5-1SB - 1MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling Micro Curved Attachment Cutting Burrs because the indications for use were broader than validated and directions were unclear.
Product
Micro Curved Attachment (MCA) Cutting Burr, DFU 18-0001. All lots are included in recall. Part Number MCA Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Issues
The Anspach Effort, Inc. is recalling MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions for use were unclear.
Product
MCA5-15SD - 1.5MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Issues
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions were unclear.
Product
MCA7-2SB - 2MM Fluted Ball, 7.3CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states
ModerateFDA (Devices)··2014-01-22
Anspach Micro Curved Attachment Cutting Burrs Recalled for Labeling Errors
The Anspach Effort, Inc. is recalling all lots of MCA Cutting Burrs and Dissection Tools because the indications for use were broader than validated and directions were unclear.
Product
MCA5-07SD - 0.7MM Diamond Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Category
Distribution
0 states