Palm Beach Gardens, FL, United States
The Anspach Effort, Inc. recalls
2 recalls recorded since 2018, most recently on 7 December 2022. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 7 December 2022
- Reason
- Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment) came out of the attachment, possibly during removal of the attachment, intra-operatively. Failure to follow the recommended inspection intervals provided in the IFU may result in serious patient injury
- Distribution
- US Nationwide and OUS Foreign: Impacted Foreign Countries Australia Bangladesh China Hongkong India Indonesia Japan Korea (Republic of) Malaysia New Zealand Philippines Singapore Taiwan, Province of China Thailand Angola Austria Belgium Croatia Cyprus Czech Republic Denmark Equatorial Guinea Finlan
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- Z-0924-2023, Z-0921-2023, Z-0922-2023, Z-0923-2023, Z-0920-2023, Z-0919-2023, Z-0917-2023, Z-0916-2023, Z-0918-2023
- Pediatric Craniotome Ref:CRANI-P-G1
- Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
- 7.5 cm Large Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-L-R Intended for cutting and shaping bone including the spine and cranium
- 6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P Intended for cutting and shaping bone including the spine and cranium
- 7.5 cm Large Craniotome Attachment Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-L Intended for cutting and shaping bone including the spine and cranium
- 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-R intended for cutting and shaping bone including the spine and cranium
- 6.5 cm Adult Craniotome, Thin Foot Plate Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-A-01 intended for cutting and shaping bone including the spine and cranium by trained medical/surgical pe
- 6.5 cm Adult Rotating Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems. Ref: CRANI-A Intended for cutting and shaping bone including the spine and cranium
- and 1 more product lines
Terminated Class II Medical devices
- Recall started
- 29 September 2017
- Terminated
- 30 July 2019
- Reason
- This voluntary recall was initiated because a veterinary unit was physically shipped in error to a non-veterinary customer account.
- Distribution
- Internationally to Canada
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0398-2018
- OSCILLATING SAW ATTACHMENT Surgical instrument motors and accessories/attachments are intended for use during surgical procedures to cut hard tissue or bone and soft tissue.
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.