Recall Z-0924-2023 ยท HBC Motor, Drill, Electric
The Anspach Effort, Inc.
Pediatric Craniotome Ref:CRANI-P-G1
| Date | Jan 7, 2023 (initiated Dec 7, 2022) |
| Status | Open, Classified |
| 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 fac |
| 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 Finlan |
| FDA record | Open on fda.gov |