The Anspach Effort, Inc. 2023-01-18 Health serious FDA
Health · FDA · Recall #FDA-Z-0924-2023
Pediatric Craniotome Ref:CRANI-P-G1 Recall
Issued January 18, 2023 · The Anspach Effort, Inc.
In January 2023, The Anspach Effort, Inc. recalled the Pediatric Craniotome Ref:CRANI-P-G1, a serious health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
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
What you should do
- 1 Stop using Pediatric Craniotome Ref:CRANI-P-G1 right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact The Anspach Effort, Inc. to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- The Anspach Effort, Inc.
- Category
- Health
- Recall date
- January 18, 2023
- Units affected
- Not reported
- Sold at
- US Nationwide and OUS Foreign: Impacted Foreign Countries Australia Bangladesh China Hongkong India Indonesia Japan Korea (Republic of) Mal
- Recall number
- FDA-Z-0924-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- The Anspach Effort, Inc. has 1 recall in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 903rd Health recall we've logged in 2023.