FDA Medical Device Recalls (openFDA)
The Anspach Effort, Inc.: 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 personnel
- Recall number
- Z-0917-2023
- Recalling firm
- The Anspach Effort, Inc.
- Product
- 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 personnel
- Status
- Open, Classified
- Initiated
- 2022-12-07
- Posted
- 2023-01-07
- Terminated
- not on file
- 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
- Root cause
- Under Investigation by firm
- Action
- DePuy Synthes initiated "URGENT: MEDICAL DEVICE CORRECTION (Notification)" via UPS on 12/07/22. Letter states reason for recall, health risk an action to be taken. The customers were instructed to do the following: Review your inventory and make a plan to follow the suggested manufacturer inspection interval of 12 months associated with your product, as specified in the IFU. " Forward this notice to anyone in your facility that needs to be informed (i.e., those who manage, transport, store, stock, or use the subject products). " If any of the subject products have been forwarded to another facility, contact that facility and provide them with this notice. " Once this notification is received, please complete, sign, and return the attached Business Response Form (page 3 of this letter) via Fax: 877-496-5042 or Scan/email: Synthes3606@sedgwick.com within 3 business days of receipt of this notification. Contact your Product Support Team through email at ra-dpyus-prodsupport@its.jnj.com or via phone at 1-800.327.6887, option #2 for additional support as needed.
- Quantity
- 6059 units in total
- 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 Finland France & French Guiana Georgia Germany Greece Hungary Israel Italy Kenya Kuwait Lebanon Lithuania Macedonia Mauritius Morocco Netherlands Poland Portugal Saudi Arabia Slovakia South Africa Spain Sweden Switzerland Turkey United Arab Emirates United Kingdom of Great Britain and Northern Ireland Argentina Bolivia Brazil Chile Colombia Costa Rica Jamaica Mexico Panama Peru Canada
- Lot, serial or model codes
- GTIN: 00845384001737 All lots
- 510(k) numbers
- ["K011444","K133604"]
- PMA numbers
- not on file
- Product code
- HBC
- Firm FEI
- 1045834
- Firm city
- Palm Beach Gardens
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28