Pediatric Craniotome Ref:CRANI-P-G1

FDA device recall Z-0924-2023 · posted 2023-01-07 · Open, Classified

Recall details

Recalling firm

The Anspach Effort, Inc.

Reason for recall

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

Action taken

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 facility, contact that facility and provide them with this notice. " Once this notification is received, please complete, sign, and return the attached Business Response Form (page 3 of this letter) via Fax: 877-496-5042 or Scan/email: Synthes3606@sedgwick.com within 3 business days of receipt of this notification. Contact your Product Support Team through email at ra-dpyus-prodsupport@its.jnj.com or via phone at 1-800.327.6887, option #2 for additional support as needed.

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

HBC

Quantity affected

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 C

Date initiated

2022-12-07

Date posted

2023-01-07

Location

Palm Beach Gardens, FL

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