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The Anspach Effort, Inc. Recall: Pediatric Craniotome Ref:CRANI-P-G1

The Anspach Effort, Inc. Recall: Pediatric Craniotome Ref:CRANI-P-G1 is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: The Anspach Effort, Inc.; Product: Pediatric Craniotome Ref:CRANI-P-G1; Reason for recall: Ball bearings in the CRANI-A (ANSPACH Power Tools Adult Craniotome Attachment)

Recalling firmThe Anspach Effort, Inc.
ProductPediatric Craniotome Ref:CRANI-P-G1
Reason for recallBall 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
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
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
Recall initiated20221207
Recall numberZ-0924-2023
Categorydevice
StateFL
CountryUnited States

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