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U.S. Department of Health and Human Services

Class 2 Device Recall Signature Patient Specific Surgical Guides

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  Class 2 Device Recall Signature Patient Specific Surgical Guides see related information
Date Initiated by Firm September 23, 2015
Date Posted October 23, 2015
Recall Status1 Terminated 3 on February 12, 2016
Recall Number Z-0162-2016
Recall Event ID 72425
510(K)Number K102795  
Product Classification Patient specific manual orthopedic stereotaxic system - Product Code OSF
Product Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
Code Information 42422461: Signature SIG CT/TI(A Guides 04-05 Slidex Distal-MP/Premier Tibial & 42422551 : Signature TKA GDE/MDL SET 03-05 MP/Premier Distal- MP/Premier Tibial  42422461 139540 2016-02-17  42-422551 1 391 51 2016-01-14  42422551 1 38805 2016-02-03  42-422551 140787 2016-03-03
Recalling Firm/
Manufacturer		 Materialise N.V.
15 Technologielaan
Heverlee Belgium
For Additional Information Contact Lisa Kamischke
724-259-7033
Manufacturer Reason
for Recall		 Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
FDA Determined
Cause 2		 Use error
Action On September 16, 2015 Materialise NV identified four cases where not all available image sets were used to design the case. On September 18, 2015, prior to the surgery dates Materialise informed (phone call) the Signature Services Manager of Zimmer Biomet that inaccuracies in the alignment of the knee might be observed with the use of the guides due to this issue. Biomet was asked to segregate the packages for these four cases and to return them to the Materialise US office. On September 23, 2015 this was followed up by e-mail notification letter with response forms. Biomet was requested to contact Materialise customer service to return these four cases and arrange a replacement set of patient specific surgical guides Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. E-mail : ortho-quality@materialise. be Customer Service Materialise USA LLC 44650 Helm Court Plymouth, Michigan 48170 734-259-7033
Quantity in Commerce 4
Distribution Distributed in MI, ID, TX, and in France.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = OSF and Original Applicant = MATERIALISE N.V.
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