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U.S. Department of Health and Human Services

Class 2 Device Recall Head Fixation Device (HFD100) Starburst adaptor thumb screw

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 Class 2 Device Recall Head Fixation Device (HFD100) Starburst adaptor thumb screwsee related information
Date Initiated by FirmAugust 14, 2017
Create DateSeptember 22, 2017
Recall Status1 Terminated 3 on May 29, 2018
Recall NumberZ-3211-2017
Recall Event ID 77996
510(K)NumberK103493 
Product Classification Holder, head, neurosurgical (skull clamp) - Product Code HBL
ProductIMRIS DEERFIELD IMAGING, REF 113803, Starburst adaptor thumb screw
Code Information Serial Numbers: 10006657, 10006658, 10006725, 10006660, 10006726, 10006659
FEI Number 3010326005
Recalling Firm/
Manufacturer		 Deerfield Imaging
5101 Shady Oak Rd S
Minnetonka MN 55343-4100
Manufacturer Reason
for Recall		incorrect thread on thumbscrews
FDA Determined
Cause 2		Process control
ActionThe firm notified the consignees by email on 08/14/2017. The letter stated that the screws would be replaced.
Quantity in Commerce6 screws
DistributionIL, OR, PA
Total Product Life CycleTPLC Device Report
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
510(K) Database510(K)s with Product Code = HBL
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