Z-0418-2015 Class II Terminated
FDA device recall Z-0418-2015 was initiated by Materialise USA LLC on October 16, 2014 and is designated Class II. 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 g… The recall status is terminated (terminated February 17, 2015). Affected quantity: 1.
Recall Details
- Product Type
- Devices
- Report Date
- December 3, 2014
- Initiation Date
- October 16, 2014
- Termination Date
- February 17, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1
Product Description
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.
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.
Distribution Pattern
Nationwide Distribution to MN only
Code Information
00-5970-000-25 JTOMA-JL-0636-L8 Pin Guide LOT#: 56602902