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Class 2 Device Recall Anspach |
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Date Initiated by Firm |
December 07, 2022 |
Date Posted |
January 07, 2023 |
Recall Status1 |
Open3, Classified |
Recall Number |
Z-0923-2023 |
Recall Event ID |
91231 |
510(K)Number |
K011444 K133604
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Product Classification |
Motor, drill, electric - Product Code HBC
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Product |
6.5 cm Pediatric Craniotome Attachment. Use with XMax¿, microMax, and eMax¿ Systems Ref: CRANI-P
Intended for cutting and shaping bone including the spine and cranium
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Code Information |
GTIN: 00845384001775
All lots
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Recalling Firm/ Manufacturer |
The Anspach Effort, Inc. 4500 Riverside Dr Palm Beach Gardens FL 33410-4235
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For Additional Information Contact |
SAME 561-627-1080
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Manufacturer 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
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FDA Determined Cause 2 |
Under Investigation by firm |
Action |
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. |
Quantity in Commerce |
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 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
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Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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510(K) Database |
510(K)s with Product Code = HBC and Original Applicant = THE ANSPACH EFFORT, INC.
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