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The Anspach Effort, Inc. Recall 91231

Description: Pediatric Craniotome Ref:CRANI-P-G1

The Anspach Effort, Inc. Recall 91231 Information

Mandated?Voluntary: Firm initiated
Recall NumberZ-0924-2023
Event ID91231
Event DescriptionPediatric Craniotome Ref:CRANI-P-G1
Product TypeDevices
DistributionUS 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
Quantity6059 units in total
Recall ReasonBall 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 Classification20230118
Device Code InfoGTIN: 00845384016403 All lots
Center Classification Date20230106
Recall Initiation Date20221207
Recalling FirmThe Anspach Effort, Inc.
Initial Notification Letter
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