Adult Craniotome, Large Ref: CRANI-L-G1 Intended for cutting and shaping bone including the spine and cranium
- Company
- The Anspach Effort, Inc.
- Recall Initiated
- December 7, 2022
- Posted
- January 7, 2023
- Recall Number
- Z-0921-2023
- Quantity
- 6059 units in total
- Firm Location
- Palm Beach Gardens, FL
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
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
Lot / Code Info
GTIN: 00845384016427 All lots
Root Cause
Under Investigation by firm
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.