The Anspach Effort, Inc. Recall 91231
Description: Pediatric Craniotome Ref:CRANI-P-G1
The Anspach Effort, Inc. Recall 91231 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0924-2023 |
| Event ID | 91231 |
| Event Description | Pediatric Craniotome Ref:CRANI-P-G1 |
| Product Type | Devices |
| 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 |
| Quantity | 6059 units in total |
| Recall 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 |
| Device Classification | 20230118 |
| Device Code Info | GTIN: 00845384016403 All lots |
| Center Classification Date | 20230106 |
| Recall Initiation Date | 20221207 |
| Recalling Firm | The Anspach Effort, Inc. |
| Initial Notification | Letter |
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