Materialise USA LLC recalls Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.

Recall date

May 3, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1941-2016

FDA classification

Class II

Brand / firm

Materialise USA LLC

Sold / distributed

One consignee, Indiana.

Why it was recalled

A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.