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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = JWH
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