Reported Dec 3, 2014 · Terminated
Zimmer Patient Specific Instrument PERSONA CR Pin Guides (Femur and Tibia) is intended to be used as a surgical…
Materialise USA LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Materialise USA LLC · 44650 Helm Ct · Plymouth, MI · 48170-6061
Is this the product you have?
- 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.
- Lot codes and dates
- 00-5970-000-25 JTOMA-JL-0636-L8 Pin Guide LOT#: 56602902
- Amount recalled
- 1
Where it was sold
- Nationwide
- MN
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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