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U.S. Department of Health and Human Services

Class 2 Device Recall Arthroline Punch

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 Class 2 Device Recall Arthroline Punchsee related information
Date Initiated by FirmJuly 24, 2017
Create DateAugust 22, 2018
Recall Status1 Open3, Classified
Recall NumberZ-2897-2018
Recall Event ID 80583
510(K)NumberK953868 
Product Classification Arthroscope - Product Code HRX
ProductArtholine Punch B 4, 6MM H 1, 6MM, used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages. Product Usage: Device is a standard punch; standard punches are used for the removal of soft tissue, cartilage tissue or other non-osseous tissue via natural or surgically created passages.
Code Information Product Number 89140.0105, Lot Number 4500197481
FEI Number 3002808001
Recalling Firm/
Manufacturer		 Richard Wolf GmbH
Pforzheimer Str. 32
Knittlingen Germany
Manufacturer Reason
for Recall		Punch may have a burr in one section of the joint and when the punch is open, there is an increase potential for injury.
FDA Determined
Cause 2		Process control
ActionThe firm notified customers on about 07/24/2018 via a Urgent safety information letter. Customers were instructed to check inventory for the affected device, return the product to Richard Wolf GmbH, and complete and return the response form. The letter also instructed customers to ensure all users in their organization are notified of the recall and to notify customers if the product was further distributed. Safety-related questions can be directed to: Tel.: 0049 7043 35 1013 Questions concerning handling can be directed to: Technical Service Dpt., Tel.: 0049 7043 35 1046
Quantity in Commerce12 units
DistributionWorldwide distribution to Germany, Hong Kong, Ireland, Romania, and Turkey.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HRX
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