FDAFDA · Food and drugs·Recall number Z-0418-2015
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.
Published December 3, 2014 · Recall initiated: October 16, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Materialise USA LLC
- Distributor
- Nationwide Distribution to MN only
- Lot
- 00-5970-000-25 JTOMA-JL-0636-L8 Pin Guide LOT#: 56602902
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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