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U.S. Department of Health and Human Services

Class 2 Device Recall Match Point System Patient specific instrumentation for shoulder arthroplasty

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 Class 2 Device Recall Match Point System Patient specific instrumentation for shoulder arthroplastysee related information
Date Initiated by FirmJuly 17, 2020
Create DateAugust 26, 2020
Recall Status1 Terminated 3 on December 23, 2020
Recall NumberZ-2886-2020
Recall Event ID 86113
510(K)NumberK153602 K170893 
Product Classification Prosthesis, shoulder, semi-constrained, metal/polymer cemented - Product Code KWS
ProductMatch Point System The Match Point System is intended to by uses as a surgical instrument to assist in the intraoperative positioning of glenoid components used with total and reverse shoulder arthroplasty by referencing anatomic landmarks of the shoulder that are identifiable on preoperative CT-image scans.
Code Information ID #s: 804-03-057, 804-25-148, 804-03-058, 804,07,022  UDI #s: E314804030570, E314804251480, E314804070220
Recalling Firm/
Manufacturer		 Materialise N.V.
Technologielaan 15
Heverlee Belgium
For Additional Information ContactCustomer Service Dept/
734-259-7014
Manufacturer Reason
for Recall		The procedure side indicated in the top header of the Shoulder Case Planning Report incorrectly indicated the procedure side as "Left" for surgical plans for a "right" procedure side.
FDA Determined
Cause 2		Software Design Change
ActionThe firm, materialise, sent Recall letters dated 17 July 2020 informing customers of the issue. This letter informs the customer that Materialise has corrected the Shoulder Case Planning Report in the SurgiCase online system. If you have any questions, contact Global Quality and Regulatory Manager Medical, at 734-259-7017 or email: Jenny.Jones@materialise.com.
Quantity in Commerce128
DistributionNationwide distribution to: US including PR and International to UK and Australia.
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 = KWS
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