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The Anspach Effort Recalls
261 recalls on record · August 1, 2012 to January 18, 2023 · Medical Devices
Recalls by year
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23
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
August 5, 2015Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH - Fluted Drum, Side Cut Only; 9MM x 14 MM REF L-9DRC-G1 Cutting shaping bone including spine and cranium.
Hazard: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
August 5, 2015Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH - Fluted Ball; 9MM REF L-9B-G1 Cutting shaping bone including spine and cranium.
Hazard: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
August 5, 2015Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH - Extra Coarse Diamond Ball; 8MM REF L-8DX-G1 Cutting shaping bone including spine and cranium.
Hazard: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
August 5, 2015Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH - 8MM x 14MM Fluted Drum, Side Cut Only; REF L-8DRC-G1. Cutting shaping bone including spine and cranium.
Hazard: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
August 5, 2015Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium.
Hazard: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
August 5, 2015Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH - Fluted Barrel; 8MM x 12.5MM REF L-8BA-G1 Cutting shaping bone including spine and cranium.
Hazard: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
August 5, 2015Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH - Fluted Drum, Side Cut Only; 7MM x 14MM REF L-7DRC-G1 Cutting shaping bone including spine and cranium.
Hazard: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
August 5, 2015Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH - Fluted Acorn, 7MM REF L-7AC-G1 Cutting shaping bone including spine and cranium.
Hazard: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
August 5, 2015Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH - Fluted Drum, Side Cut only, 6MM x 14MM REF L-6DRC-G1 Cutting shaping bone including spine and cranium.
Hazard: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
August 5, 2015Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH - Extra Coarse Diamond Drum, 6.8MM x 10.6MM REF L-68DRMDX-G1 Cutting shaping bone including spine and cranium
Hazard: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
August 5, 2015Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH - Fluted Drum, Side Cut only 5MM x 14MM , REF L-5DRC-G1. Cutting shaping bone including spine and cranium.
Hazard: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
August 5, 2015Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH - Fluted Drum, Side Cut only 10MM x 14MM , REF L-10DRC-G1 Cutting shaping bone including spine and cranium.
Hazard: G1 Dissection Tools are not compatible with all attachments listed on the labeling; G1 cutting tools are labeled with a Specified Shaft Exposure which may not be consistent when used with each attachment on the product label. Shaft exposure may be greater.
May 6, 2015Medical DevicesFDA
The Anspach Effort, Inc. recalls Synthes Small Battery Drive (SBD) Oscillating Saw Attachment Part Number: 532.021 for orthopedic surgery.
Hazard: The potential exists for the Oscillating Saw Attachment to disengage from the Small Battery Drive handpiece. If the attachment disengages from the handpiece intra-operatively, there is a potential for injury to the patient and/or user.
February 11, 2015Medical DevicesFDA
The Anspach Effort, Inc. recalls 16cm Minimally Invasive Attachment. For use with Motor Systems for cutting and shaping bones, including the spine and c
Hazard: Customer complaint indicating the color bands on the MIA16-G1 were not correct.
July 9, 2014Medical DevicesFDA
The Anspach Effort, Inc. recalls Anspach Pneumatic and Electric Motor Systems. Intended for cutting and shaping bone, including the spine and cranium.
Hazard: Several attachments and handpieces failed to meet the expected sterility assurance level (SAL) when sterilized by the method that is specified in the current Directions for Use (DFU) provided with the device.
July 2, 2014Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH***REF 98-0033***Custom Autolube Food Guard***Rx Only*** This device is intended to be used with Anspach Syste
Hazard: 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.
July 2, 2014Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH***REF 98-0012***Shoulder Implant 011mm Rod, 20cm Long, Custom***Rx Only*** This device is intended to be used
Hazard: 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.
July 2, 2014Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH***REF SP-5001-00***20 degree Angle Driver (MA-D20) - Custom***Rx Only*** This device is intended to be used w
Hazard: 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.
July 2, 2014Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH***REF SP-5000-00***Threaders, Arthroscopic Suture Anchor***Rx Only*** This device is intended to be used with
Hazard: 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.
July 2, 2014Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH***Arthroscopic Knotless Suture Anchor***Rx Only*** This device is intended to be used with Anspach Systems
Hazard: 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.
July 2, 2014Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH***REF SP-4605-00***Arthroscopic Suture Anchor assembly with Suture Threader***Rx Only*** This device is inten
Hazard: 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.
July 2, 2014Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH***REF SP-4604-00***3mm Fluted Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is intended to
Hazard: 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.
July 2, 2014Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH***REF SP-4603-00***3mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is int
Hazard: 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.
July 2, 2014Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH***REF SP-4602-00***2mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is int
Hazard: 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.
July 2, 2014Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH***REF SP-4601-00***1mm Coarse Diamond Ball for Adjustable 25cm Mia Attachment***Rx Only*** This device is int
Hazard: 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.
July 2, 2014Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH***REF SP-3101-00***Adjustable 25 Cm Mia Attachment, Custom***Rx Only*** This device is intended to be used wi
Hazard: 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.
July 2, 2014Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH***REF SP-3100-00***5mm Coarse Diamond Ball, 11.5 OAL***Rx Only*** This device is intended to be used with Ans
Hazard: 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.
July 2, 2014Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH***REF SP-3014-00***4mm Fluted Ball for MRI***Rx Only*** This device is intended to be used with Anspach Syst
Hazard: 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.
July 2, 2014Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH***1.85mm x 16 mm Fluted Router for MRI***Rx Only*** This device is intended to be used with Anspach Systems
Hazard: 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.
July 2, 2014Medical DevicesFDA
The Anspach Effort, Inc. recalls ANSPACH***REF SP-3012-00***13 mm Drill with Depth Stop for Short Heavy Duty Attachment***Rx Only*** This device is in
Hazard: 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.