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U.S. Department of Health and Human Services

Class 2 Device Recall Zimmer Patient Specific Instrument PERSONA CR Pin Guides

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  Class 2 Device Recall Zimmer Patient Specific Instrument PERSONA CR Pin Guides see related information
Date Initiated by Firm October 16, 2014
Date Posted November 21, 2014
Recall Status1 Terminated 3 on February 17, 2015
Recall Number Z-0418-2015
Recall Event ID 69632
510(K)Number K121640  
Product Classification Prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer - Product Code JWH
Product Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical instrument to assist in the positioning of Total Knee Replacement components intraoperatively and in guiding the marking of bone before cutting provided that anatomic landmarks necessary for alignment and positioning of the implant are identifiable on patient imaging scans.
Code Information 00-5970-000-25 JTOMA-JL-0636-L8 Pin Guide LOT#: 56602902
Recalling Firm/
Manufacturer		 Materialise USA LLC
44650 Helm Ct
Plymouth MI 48170-6061
For Additional Information Contact Joel Tiemeyer
734-662-5057
Manufacturer Reason
for Recall		 The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Materialise USA was notified on October 16, 2014 by the Field Representative of the distributor (Zimmer) that the box of guides for case JTOMA-JL-0636-L arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. A new set of tibial and femoral guides were manufactured and sent to Zimmer (headquarters distribution center) on October 17, 2014 before the surgery date on October 20, 2014. For questions regarding this recall call 734-662-5057.
Quantity in Commerce 1
Distribution Nationwide Distribution to MN only
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 = JWH and Original Applicant = MATERIALISE N.V.
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